6,056 Gmp Manager jobs in the United States

GMP MANAGER

27539 Apex, North Carolina Compass Group, North America

Posted 6 days ago

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Job Description

ESFM

**Position Title: GMP MANAGER**

**Salary:** **$70,000 - $80,000**

**Pay Grade: 13**

**Other Forms of Compensation:** Bonus

ESFM is the corporate facilities management (FM) division of Compass Group USA, a Gold-level Corporate Sustaining Partner of the International Facility Management Association (IFMA), and a Platinum Corporate Member of the Association of Energy Engineers (AEE).

ESFM self-performs 80% of all FM services provided to clients. Our portfolio of solution categories includes Facilities Maintenance&Engineering, ESG Programming, Laboratory Support Services, Janitorial&Industrial Cleaning, Landscaping&Grounds Management, Workplace Solutions and Managed Services.

This self-performance model creates a consistent hospitality experience for clients, resulting in higher engagement and productivity from their employees. ESFM's clients include many household names from the life sciences, technology, oil&gas and manufacturing markets.

**_This position is eligible for an Employee Referral Bonus! If you know someone that is qualified for this role, please use the 'job search' in PeopleHub to refer your referral and email them a link to apply. Your referral will be able to apply by clicking the link in the email. You can check the status through your profile, accessible via Careers in PeopleHub, by clicking on 'referral tracking.' For Employee Referral guidelines, FAQs and the Compass Employee Referral Policy, email **

**Job Summary**

Summary: As a **GMP Manager,** you will be responsible for assisting in the successful operation and customer service of the EVS/housekeeping department

**Essential Duties and Responsibilities:**

Maintains a high level of cleanliness in assigned areas.

Participates in recruitment and staff selection process.

Assists with housekeeper scheduling.

Assigns established work areas and or project duties.

Plans and coordinates project work.

Attends and participates in departmental staff meetings, development and training courses.

Provides and monitors individual guidance and motivation to employees.

Participates in facility Quality Assurance Program as required.

Works with chemicals on a constant basis requiring special clothing or safety equipment.

Assigns equipment to staff; monitors daily equipment use, cleaning and maintenance.

Ensures that all equipment is clean and professional in appearance at all times.

Assists housekeepers on an as needed basis.

Performs other duties as assigned.

**Qualifications** :

4 years of support services, housekeeping, and/or facilities maintenance experience.

1 or more years of supervisory/management experience.

Strong work ethic, intense drive, and initiative for quality and customer service.

Excellent written and oral communication skills.

Excellent problem-solving skills both one-on-one and in group situations.

Ability to utilize a participative approach to managing staff.

Understanding of budgeting processes and awareness of profit and loss concepts.

Excellent administrative and organizational skills and an ability to prioritize.

Ability to function appropriately under stressful conditions.

CRCST or any other applicable sterile processing certification is preferred.

Proficient computer skills and knowledge of MS Office products, including Word, Excel, PowerPoint, Outlook, and the internet.

GMP is preferred

**Apply to ESFM Services today!**

_ESFM is a member of Compass Group USA_

Click here to Learn More about the Compass Story ( Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act.**

Applications are accepted on an ongoing basis.

Eurest Services maintains a drug-free workplace.

**Associates at ESFM are offered many fantastic benefits.**

+ Medical

+ Dental

+ Vision

+ Life Insurance/ AD

+ Disability Insurance

+ Retirement Plan

+ Paid Time Off

+ Holiday Time Off (varies by site/state)

+ Associate Shopping Program

+ Health and Wellness Programs

+ Discount Marketplace

+ Identity Theft Protection

+ Pet Insurance

+ Commuter Benefits

+ Employee Assistance Program

+ Flexible Spending Accounts (FSAs)

+ Paid Parental Leave

+ Personal Leave

Associates may also be eligible for paid and/or unpaid time off benefits in accordance with applicable federal, state, and local laws. For positions in Washington State, Maryland, or to be performed Remotely, click here ( for paid time off benefits information.

Req ID:1442732

ESFM

Brandy Wilson
View Now

GMP MANAGER

27539 Apex, North Carolina Compass Group USA Inc

Posted 7 days ago

Job Viewed

Tap Again To Close

Job Description

ESFM

Position Title: GMP MANAGER

Salary: $70,000 - $80,000

Pay Grade: 13

Other Forms of Compensation: Bonus

ESFM is the corporate facilities management (FM) division of Compass Group USA, a Gold-level Corporate Sustaining Partner of the International Facility Management Association (IFMA), and a Platinum Corporate Member of the Association of Energy Engineers (AEE).

ESFM self-performs 80% of all FM services provided to clients. Our portfolio of solution categories includes Facilities Maintenance & Engineering, ESG Programming, Laboratory Support Services, Janitorial & Industrial Cleaning, Landscaping & Grounds Management, Workplace Solutions and Managed Services.

This self-performance model creates a consistent hospitality experience for clients, resulting in higher engagement and productivity from their employees. ESFM's clients include many household names from the life sciences, technology, oil & gas and manufacturing markets.

This position is eligible for an Employee Referral Bonus! If you know someone that is qualified for this role, please use the 'job search' in PeopleHub to refer your referral and email them a link to apply. Your referral will be able to apply by clicking the link in the email. You can check the status through your profile, accessible via Careers in PeopleHub, by clicking on 'referral tracking.' For Employee Referral guidelines, FAQs and the Compass Employee Referral Policy, email

Job Summary

Summary: As a GMP Manager, you will be responsible for assisting in the successful operation and customer service of the EVS/housekeeping department

Essential Duties and Responsibilities:

Maintains a high level of cleanliness in assigned areas.

Participates in recruitment and staff selection process.

Assists with housekeeper scheduling.

Assigns established work areas and or project duties.

Plans and coordinates project work.

Attends and participates in departmental staff meetings, development and training courses.

Provides and monitors individual guidance and motivation to employees.

Participates in facility Quality Assurance Program as required.

Works with chemicals on a constant basis requiring special clothing or safety equipment.

Assigns equipment to staff; monitors daily equipment use, cleaning and maintenance.

Ensures that all equipment is clean and professional in appearance at all times.

Assists housekeepers on an as needed basis.

Performs other duties as assigned.

Qualifications:

4 years of support services, housekeeping, and/or facilities maintenance experience.

1 or more years of supervisory/management experience.

Strong work ethic, intense drive, and initiative for quality and customer service.

Excellent written and oral communication skills.

Excellent problem-solving skills both one-on-one and in group situations.

Ability to utilize a participative approach to managing staff.

Understanding of budgeting processes and awareness of profit and loss concepts.

Excellent administrative and organizational skills and an ability to prioritize.

Ability to function appropriately under stressful conditions.

CRCST or any other applicable sterile processing certification is preferred.

Proficient computer skills and knowledge of MS Office products, including Word, Excel, PowerPoint, Outlook, and the internet.

GMP is preferred

Apply to ESFM Services today!

ESFM is a member of Compass Group USA

Click here to Learn More about the Compass Story

Compass Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act.

Applications are accepted on an ongoing basis.

Eurest Services maintains a drug-free workplace.

Associates at ESFM are offered many fantastic benefits.

* Medical
* Dental
* Vision
* Life Insurance/ AD
* Disability Insurance
* Retirement Plan
* Paid Time Off
* Holiday Time Off (varies by site/state)
* Associate Shopping Program
* Health and Wellness Programs
* Discount Marketplace
* Identity Theft Protection
* Pet Insurance
* Commuter Benefits
* Employee Assistance Program
* Flexible Spending Accounts (FSAs)
* Paid Parental Leave
* Personal Leave

Associates may also be eligible for paid and/or unpaid time off benefits in accordance with applicable federal, state, and local laws. For positions in Washington State, Maryland, or to be performed Remotely, click here for paid time off benefits information.

Req ID:1442732

ESFM

Brandy Wilson
View Now

GMP MANAGER

27539 Apex, North Carolina Compass Group, North America

Posted 9 days ago

Job Viewed

Tap Again To Close

Job Description

ESFM
**Position Title: GMP MANAGER**
**Salary:** **$70,000 - $80,000**
**Pay Grade: 13**
**Other Forms of Compensation:** Bonus
ESFM is the corporate facilities management (FM) division of Compass Group USA, a Gold-level Corporate Sustaining Partner of the International Facility Management Association (IFMA), and a Platinum Corporate Member of the Association of Energy Engineers (AEE).
ESFM self-performs 80% of all FM services provided to clients. Our portfolio of solution categories includes Facilities Maintenance&Engineering, ESG Programming, Laboratory Support Services, Janitorial&Industrial Cleaning, Landscaping&Grounds Management, Workplace Solutions and Managed Services.
This self-performance model creates a consistent hospitality experience for clients, resulting in higher engagement and productivity from their employees. ESFM's clients include many household names from the life sciences, technology, oil&gas and manufacturing markets.
**_This position is eligible for an Employee Referral Bonus! If you know someone that is qualified for this role, please use the 'job search' in PeopleHub to refer your referral and email them a link to apply. Your referral will be able to apply by clicking the link in the email. You can check the status through your profile, accessible via Careers in PeopleHub, by clicking on 'referral tracking.' For Employee Referral guidelines, FAQs and the Compass Employee Referral Policy, email **
**Job Summary**
Summary: As a **GMP Manager,** you will be responsible for assisting in the successful operation and customer service of the EVS/housekeeping department
**Essential Duties and Responsibilities:**
Maintains a high level of cleanliness in assigned areas.
Participates in recruitment and staff selection process.
Assists with housekeeper scheduling.
Assigns established work areas and or project duties.
Plans and coordinates project work.
Attends and participates in departmental staff meetings, development and training courses.
Provides and monitors individual guidance and motivation to employees.
Participates in facility Quality Assurance Program as required.
Works with chemicals on a constant basis requiring special clothing or safety equipment.
Assigns equipment to staff; monitors daily equipment use, cleaning and maintenance.
Ensures that all equipment is clean and professional in appearance at all times.
Assists housekeepers on an as needed basis.
Performs other duties as assigned.
**Qualifications** :
4 years of support services, housekeeping, and/or facilities maintenance experience.
1 or more years of supervisory/management experience.
Strong work ethic, intense drive, and initiative for quality and customer service.
Excellent written and oral communication skills.
Excellent problem-solving skills both one-on-one and in group situations.
Ability to utilize a participative approach to managing staff.
Understanding of budgeting processes and awareness of profit and loss concepts.
Excellent administrative and organizational skills and an ability to prioritize.
Ability to function appropriately under stressful conditions.
CRCST or any other applicable sterile processing certification is preferred.
Proficient computer skills and knowledge of MS Office products, including Word, Excel, PowerPoint, Outlook, and the internet.
GMP is preferred
**Apply to ESFM Services today!**
_ESFM is a member of Compass Group USA_
Click here to Learn More about the Compass Story ( Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act.**
Applications are accepted on an ongoing basis.
Eurest Services maintains a drug-free workplace.
**Associates at ESFM are offered many fantastic benefits.**
+ Medical
+ Dental
+ Vision
+ Life Insurance/ AD
+ Disability Insurance
+ Retirement Plan
+ Paid Time Off
+ Holiday Time Off (varies by site/state)
+ Associate Shopping Program
+ Health and Wellness Programs
+ Discount Marketplace
+ Identity Theft Protection
+ Pet Insurance
+ Commuter Benefits
+ Employee Assistance Program
+ Flexible Spending Accounts (FSAs)
+ Paid Parental Leave
+ Personal Leave
Associates may also be eligible for paid and/or unpaid time off benefits in accordance with applicable federal, state, and local laws. For positions in Washington State, Maryland, or to be performed Remotely, click here ( for paid time off benefits information.
Req ID:1442732
ESFM
Brandy Wilson
View Now

GMP Program Manager

95828 Florin, California University of California-Davis

Posted 6 days ago

Job Viewed

Tap Again To Close

Job Description

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Job Summary

The GMP Program Manager is a leadership member of the Stem Cell Program, Good Manufacturing Practice (GMP) team and reports to the Stem Cell Program, Program Manager with a dotted line (for compliance responsibilities) to the Stem Cell Program Director (Dr. Nolta). UC Davis Health is investing in Cell and Gene Therapy across the School of Medicine and Medical Center. This position is tightly aligned with the goals of the implementation of this 10-year business plan for this UCDH-level strategic initiative.

Job Summary

The GMP Program Manager is a leadership member of the Stem Cell Program, Good Manufacturing Practice (GMP) team and reports to the Stem Cell Program, Program Manager with a dotted line (for compliance responsibilities) to the Stem Cell Program Director (Dr. Nolta). UC Davis Health is investing in Cell and Gene Therapy across the School of Medicine and Medical Center. This position is tightly aligned with the goals of the implementation of this 10-year business plan for this UCDH-level strategic initiative.

The position provides complex project leadership related to the GMPs growth projections including managing projects to ensure operational optimization. To provide effective project and contract management, the incumbent analyzes and recommends novel solutions, interprets policies regarding operational management to ensure optimal efficiency and work product, oversees timelines, and applies subject matter knowledge in manufacturing. The position will be responsible for fostering and managing internal and external partnership and apply evidenced-based project management expertise to organize multiple workstreams simultaneously. Related to internal and external projects, responsibilities include operating expense/revenue budgets, supply chain management and equipment procurement, and the creation and distribution of operational reports. Incumbent manages projects primarily for the GMP, but the portfolio may span multiple CGT teams including preclinical and clinical research, as well as contracts, grants and corporate sponsors associate with the broader Cell and Gene Therapy Initiative.

Additional responsibilities are to provide leadership of the Quality Assurance team, including the design/refinement of supply management processes, laboratory management, and the preparation of operational reports regarding compliance with departmental goals and objectives. The incumbent will work closely with School of Medicine (SOM) Dean's Office, SOM Finance Unit, sponsoring entities, Sponsored Programs (SPO), UC Davis Health Contracts and Information Technology resources to develop written guidelines, procedures and policies to ensure efficiency, consistency and compliance with UCDH administrative regulations and requirements for the various projects.

Apply By Date: 8/19/2025 by 11:59pm

Minimum Qualifications - For full consideration, applicants are encouraged to upload license and/or certification if required of the position

  • Bachelors degree in related area and/or equivalent experience/training.
  • At least seven years of experience in cell and gene therapy manufacturing.
  • At least two years of experience in a customer facing commercial role.
  • At least two years of experience managing client projects.
  • At least two years applying evidence-based project management tools and methodologies.
  • At least two or more years of tissue and cell culture experience, including cell lines, primary cells, MSC, iPSC, and HSC.
  • Experience managing a large, very complex, multifaceted department, or business unit.
  • Experience supervising and managing a diverse group of employees.
  • Experience in research laboratory supply management.
  • Extensive experience in strategic planning.
  • Expertise in relationship management, including supervisory experience in an academic setting.
  • Extensive track record in project management and a strong background minimum 10 years in human stem cell and gene therapy products
  • Ability to assess complex project opportunities, and analyzing project timelines, resources, and budget information with demonstrated knowledge of grant funding processes and procedures
  • Demonstrated skills with technical documentation and CMC preparation for acceptance by regulatory and Federal Agencies for the purpose of IND submission.
  • Knowledge of cell and gene therapy manufacturing workflows and project stages
  • Client facing knowledge and ability to interface between internal and external stakeholders
  • Demonstrated ability to work selflessly in a service role, to help multiple investigators, rather than to focus on a preferred project. High level of experience in cell biology and advanced molecular biology techniques.
  • Knowledge of operating under FDA-compliant procedures and methods to obtain data for prePre-IND, Pre-IND, and IND applications
  • Demonstrated ability to work independently, with emphasis on the ability to closely follow SOPs.
  • Ability to organize data, and maintain accurate records
  • Demonstrated organization skills to set work priorities with pressure of deadlines.
  • Excellent interpersonal and communication skills, both verbal and written, to understand and appropriately respond to multiple and frequent inquiries, requests, and instructions in a courteous, cooperative, and professional manner.
  • Advanced level of supervising staff and students in an academic or research setting.
  • Academic background in relevant area of research.
  • Ability to build relationships, collaborate and problem solve both internally and with external organizations.
  • Demonstrated knowledge of program development as well as project proposal development and administration.
  • Demonstrated leadership skills including effective communication, negotiation, coaching, and conflict resolution.
  • Advanced oral and written communication skills with the ability to communicate effectively with diverse stakeholders.
  • Knowledge of human resources management practices and policies.
  • Knowledge of financial principles and budget practices.

Preferred Qualifications

  • Doctoral degree in a related field
  • At least three years of experience in an academic health care setting.
  • Five or more years managing client projects.
  • Five or more years managing academic core operations.
  • Five or more years of tissue and cell culture experience, including cell lines, primary cells, MSC, iPSC, and HSC.
  • Experience with BUA and SCRO submissions, amendments, and maintenance.
  • Advanced experience with GMP quality management systems.
  • Extensive experience with and understanding of the Health System organization and executive administrative leadership.
  • Advanced ability and/or skills to develop and review complicated, multi-year, multi-funded projects budget in accordance with sponsor guidelines.
  • Demonstrated ability and/or skills creating and formatting spreadsheets and databases.
  • Knowledge or ability to understand University fund accounting, generally accepted accounting principles and government auditing standards.
  • Knowledge of University contracts/grants, financial, accounting and payroll policies and procedures.
  • Demonstrated knowledge university, state, and federal policies that influence higher education.

Key Responsibilities

  • 55% - Project Management and Contracts Management
  • 30% - Quality Control Operations Supervision
  • 15% - GMP Facility & Inventory Management

Department Overview

The Good Manufacturing Practice Facility (GMP) is a recognized as the largest academic GMP in Northern California. The GMP team reports to Stem Cell Program leadership; the Stem Cell Program is an internationally recognized basic, translational science and clinical research program committed to finding treatments and cures for debilitating human diseases and injuries utilizing the full range of human stem cells. The program includes affiliates from numerous departments across the Sacramento and Davis campuses. The purpose of the Good Manufacturing Practice (GMP) Facility is to manufacture clinical grade stem cell and other cellular therapy products, gene therapy products, pharmaceutical products and formulations for novel or routine patient treatments and clinical trials, and to perform scholarly research and development when appropriate.

Department Specific Job Scope

The GMP is dedicated to the production of clinical-grade stem cell therapies, gene therapy products, and pharmaceutical formulations for use in clinical trials and novel or routine patient treatments. Operating under strict regulatory standards, the facility ensures compliance with current Good Manufacturing Practices (cGMP) while supporting translational research, product development, and technology transfer. In addition to manufacturing, the facility contributes to scholarly innovation by advancing biomanufacturing methods and collaborating with investigators to bring promising therapies from bench to bedside.

POSITION INFORMATION

  • Salary or Pay Range: $102,400.00 - $02,400.00
  • Salary Frequency: Monthly
  • Monthly Salary: 8,533.33 - 16,866.66
  • Salary Grade: Grade 25
  • UC Job Title: ACAD PRG MGT SUPV 2
  • UC Job Code: 006832
  • Number of Positions: 1
  • Appointment Type: Staff: Career
  • Percentage of Time: 100%
  • Shift (Work Schedule): Day
  • Location: UCD Inst for Regenerative Cure (HSP041)
  • Union Representation: 99 - Non-Represented (PPSM)
  • Benefits Eligible: Yes
  • This position is 100% on-site
  • This is not an H-1B opportunity

Benefits

Outstanding benefits and perks are among the many rewards of working for the University of California. UC Davis offers a full range of benefits, resources and programs to help you bring your best self to work, as well as to help you and your family achieve your health, wellness, financial and career goals. Learn more about the benefits below and eligibility rules by visiting either our handy Benefits Summary for UC Davis Health Employees or Benefits Summary for UC Davis Employees and our Benefits Page.

If you are represented by a union, benefits are negotiated between the University of California (UC) and your union and finalized in a contract. Read your bargaining unit's employment contract, stay abreast of current negotiations and learn about collective bargaining at UC:

  • High quality and low-cost medical plans to choose from to fit your familys needs
  • UC pays for Dental and Vision insurance premiums for you and your family
  • Extensive leave benefits including Pregnancy and Parental Leave, Family & Medical Leave
  • Paid Holidays annually as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
  • Paid Time Off/Vacation/Sick Time as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
  • Continuing Education (CE) allowance and Education Reimbursement Program as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
  • Access to free professional development courses and learning opportunities for personal and professional growth
  • WorkLife and Wellness programs and resources
  • On-site Employee Assistance Program including access to free mental health services
  • Supplemental insurance offered including additional life, short/long term disability, pet insurance and legal coverage
  • Public Service Loan Forgiveness (PSFL) Qualified Employer & Student Loan Repayment Assistance Program for qualified roles
  • Retirement benefit options for eligible roles including Pension and other Retirement Saving Plans. More information on our retirement benefits can be found here

Physical Demands

  • Standing - Occasional Up to 3 Hours
  • Walking - Occasional Up to 3 Hours
  • Sitting - Frequent 3 to 6 Hours
  • Lifting/Carrying 0-25 Lbs - Occasional Up to 3 Hours
  • Lifting/Carrying 26-50 lbs - Occasional Up to 3 Hours
  • Pushing/Pulling 0-25 Lbs - Occasional Up to 3 Hours
  • Pushing/Pulling 26-50 lbs - Occasional Up to 3 Hours
  • Pushing/Pulling over 50 lbs - Occasional Up to 3 Hours
  • Bending/Stooping - Occasional Up to 3 Hours
  • Squatting/Kneeling - Occasional Up to 3 Hours
  • Twisting - Occasional Up to 3 Hours
  • Reaching overhead - Occasional Up to 3 Hours
  • Keyboard use/repetitive motion - Frequent 3 to 6 Hours

Environmental Demands

  • Chemicals, dust, gases, or fumes - Occasional Up to 3 Hours
  • Loud noise levels - Occasional Up to 3 Hours
  • Operating motor vehicles and/or equipment - Occasional Up to 3 Hours
  • Uneven Surfaces or Elevations - Occasional Up to 3 Hours

Mental Demands

  • Sustained attention and concentration - Frequent 3 to 6 Hours
  • Complex problem solving/reasoning - Frequent 3 to 6 Hours
  • Ability to organize & prioritize - Continuous 6 to 8+ Hours
  • Communication skills - Continuous 6 to 8+ Hours
  • Numerical skills - Frequent 3 to 6 Hours
  • Constant Interaction - Continuous 6 to 8+ Hours
  • Customer/Patient Contact - Continuous 6 to 8+ Hours
  • Multiple Concurrent Tasks - Continuous 6 to 8+ Hours

Work Environment

UC Davis is a smoke and tobacco free campus effective January 1, 2014. Smoking, the use of smokeless tobacco products, and the use of unregulated nicotine products (e-cigarettes) will be strictly prohibited on any UC Davis owned or leased property, indoors and outdoors, including parking lots and residential space.

Non-smoking workplace. Occasional overtime may be required. The position is subject to a criminal background investigation

Special Requirements Please contact your recruiter with questions regarding which activities apply by position

  • This is a critical position, as defined by UC Policy and local procedures, and as such, employment is contingent upon clearing a criminal background check(s) and may include drug screening, medical evaluation clearance and functional capacity assessment
  • This position is designated as a mandated reporter under CANRA and UC policy, and employment is contingent on compliance with applicable policies, procedures and training requirements

Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

A Culture of Opportunity and Belonging

At UC Davis, were committed to solving lifes most urgent challenges and building a healthier, more resilient world. We believe in growing through every challenge, continually striving to improve, and welcoming new perspectives that strengthen our community. We recognize that a vibrant and innovative organization values both individual strengths and shared purpose. The best ideas often emerge when people with different experiences come together.

As you consider joining UC Davis, we invite you to explore our Principles of Community, our Clinical Strategic Plan and strategic vision for research and education. We believe you belong here. The University of California, Davis is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

To view the University of Californias Anti-Discrimination Policy, please visit:

Because we want you to feel seen and valued, our recruitment process at UC Davis supports openness and authenticity. Research shows that some individuals hesitate to apply unless they meet every qualification. You may be an excellent fit for this role-or the next one. We encourage you to apply even if your experience doesn't match every listed requirement. #YouBelongHere

To learn more about our background check program, please visit: Seniority level
  • Seniority level Director
Employment type
  • Employment type Full-time
Job function
  • Job function Project Management and Information Technology
  • Industries Higher Education

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GMP Cleaning Manager

77246 Houston, Texas ABM Industries

Posted 19 days ago

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Job Description

Job Description

The Operations Manager is responsible for delivering exceptional client service through the effective management of Integrated Facility Solutions (IFS) at a designated site. This role oversees facility services, cleaning operations, and contract management, ensuring compliance with ISO, FDA, cGMP, and cleanroom standards. A strong, process-driven leader, the Operations Manager drives operational excellence, cost efficiency, and client satisfaction while identifying opportunities for service expansion across all ABM lines.

Benefits:

ABM offers a comprehensive benefits package. For information about ABM's benefits, visit Employee Benefits | Staff & Management

Key Responsibilities:
  • Champion a culture of safety and manage the site's safety program.
  • Lead preventive and reactive maintenance programs across mechanical, electrical, plumbing, carpentry, janitorial, and infrastructure systems.
  • Oversee cleaning operations, including general office and cleanroom environments.
  • Manage vendor contracts (e.g., security, pest control, food services, landscaping).
  • Supervise 5-8 direct reports and approximately 25 on-site staff.
  • Ensure compliance with client and ABM CMMS/work order systems.
  • Monitor and improve service quality through inspections and client feedback.
  • Develop and implement process improvements to meet cost-saving goals.
  • Manage a multimillion-dollar budget, ensuring profitability and operational efficiency.
  • Handle payroll, performance reviews, hiring, and disciplinary actions.
  • Maintain strong client relationships and resolve service issues promptly.
Qualifications:

Education & Experience:
  • Bachelor's degree
  • Minimum 5 years of management experience in facilities or operations.
  • Proven ability to lead, train, and develop teams.
  • Strong communication and interpersonal skills.
  • Experience with P&L analysis and financial reporting.
  • Familiarity with ISO, FDA, cGMP, and cleanroom operations.
Skills & Competencies:
  • Self-starter with strong problem-solving abilities.
  • Comfortable working in fast-paced, regulated environments.
  • Proficient in ABM systems and Microsoft Office Suite.
  • Bilingual in Spanish is a plus.
Work Environment:
  • Office, shop, and biopharmaceutical production settings (cleanrooms, labs).
  • Occasional exposure to boiler/chiller operations and outdoor environments.
Reporting Structure:
  • Reports to the National Account Director.
  • Daily interaction with clients and on-site teams.


About Us

ABM (NYSE: ABM) is one of the world's largest providers of integrated facility, engineering, and infrastructure solutions. Every day, our over 100,000 team members deliver essential services that make spaces cleaner, safer, and efficient, enhancing the overall occupant experience.

ABM serves a wide range of market sectors including commercial real estate, aviation, education, mission critical, and manufacturing and distribution. With over $8 billion in annual revenue and a blue-chip client base, ABM delivers innovative technologies and sustainable solutions that enhance facilities and empower clients to achieve their goals. Committed to creating smarter, more connected spaces, ABM is investing in the future to meet evolving challenges and build a healthier, thriving world. ABM: Driving possibility, together.

ABM is an Equal Employment Opportunity (EEO) employer that does not discriminate on the basis of any trait or characteristic protected by applicable federal, state, or local law, including disability and protected veteran status. ABM is committed to working with and providing reasonable accommodation to individuals with disabilities. If you have a disability and need assistance in completing the employment application, please call . We will provide you with assistance and make a determination on your request for reasonable accommodation on a case-by-case basis.

ABM participates in the U.S. Department of Homeland Security E-Verify program. E-Verify is an internet-based system used to electronically confirm employment eligibility.

ABM is a military-friendly company proudly employing thousands of men and women who have served in the U.S. military. With ABM, you'll have access to a world-class training program and ample opportunities to use the skills you developed while serving our country. Whether you're looking for a frontline or professional position, you can find post-military career opportunities across ABM.

ABM directs all applicants to apply at ABM does not accept unsolicited resumes.

For more information, visit
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GMP Cleaning Manager

77007 Houston, Texas ABM Industries

Posted 4 days ago

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Job Description

**Overview**
The Operations Manager is responsible for delivering exceptional client service through the effective management of Integrated Facility Solutions (IFS) at a designated site. This role oversees facility services, cleaning operations, and contract management, ensuring compliance with ISO, FDA, cGMP, and cleanroom standards. A strong, process-driven leader, the Operations Manager drives operational excellence, cost efficiency, and client satisfaction while identifying opportunities for service expansion across all ABM lines.
**Benefits:**
ABM offers a comprehensive benefits package. For information about ABM's benefits, visit Employee Benefits | Staff & Management ( Responsibilities:**
+ Champion a culture of safety and manage the site's safety program.
+ Lead preventive and reactive maintenance programs across mechanical, electrical, plumbing, carpentry, janitorial, and infrastructure systems.
+ Oversee cleaning operations, including general office and cleanroom environments.
+ Manage vendor contracts (e.g., security, pest control, food services, landscaping).
+ Supervise 5-8 direct reports and approximately 25 on-site staff.
+ Ensure compliance with client and ABM CMMS/work order systems.
+ Monitor and improve service quality through inspections and client feedback.
+ Develop and implement process improvements to meet cost-saving goals.
+ Manage a multimillion-dollar budget, ensuring profitability and operational efficiency.
+ Handle payroll, performance reviews, hiring, and disciplinary actions.
+ Maintain strong client relationships and resolve service issues promptly.
**Qualifications:**
**Education & Experience:**
+ Bachelor's degree
+ Minimum 5 years of management experience in facilities or operations.
+ Proven ability to lead, train, and develop teams.
+ Strong communication and interpersonal skills.
+ Experience with P&L analysis and financial reporting.
+ Familiarity with ISO, FDA, cGMP, and cleanroom operations.
**Skills & Competencies:**
+ Self-starter with strong problem-solving abilities.
+ Comfortable working in fast-paced, regulated environments.
+ Proficient in ABM systems and Microsoft Office Suite.
+ Bilingual in Spanish is a plus.
**Work Environment:**
+ Office, shop, and biopharmaceutical production settings (cleanrooms, labs).
+ Occasional exposure to boiler/chiller operations and outdoor environments.
**Reporting Structure:**
+ Reports to the National Account Director.
+ Daily interaction with clients and on-site teams.
REQNUMBER: 124813
ABM is proud to be an Equal Opportunity Employer qualified applicants without regard race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran or any other protected factor under federal, state, or local law. ABM is committed to working with and providing reasonable accommodation to individuals with disabilities. If you have a disability and need assistance in completing the employment application, please call . We will provide you with assistance and make a determination on your request for reasonable accommodation on a case-by-case basis.
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Product Manager - GMP

02472 Watertown, Massachusetts Refeyn Ltd

Posted 1 day ago

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Job Description

The Role:

The Product Manager should guide NPI and further development of our disruptive analytical solutions for Biopharma GMP-regulated environments. The successful candidate will work at the interface between key customers, product marketing managers and the R&D teams to deliver winning product solutions. Building on an exceptional market opportunity, this is a great chance to shape the product portfolio of a high-growth scale-up company.

Primary responsibilities for this role include:

Product Strategy and Vision:
  • Define the product vision and strategy in alignment with the company's overall goals and market trends.
  • Develop and maintain a product roadmap that reflects customer needs, business priorities, and technological advancements.
Market Research and Analysis:
  • Conduct market research to identify customer needs, competitive landscape, and emerging trends.
  • Analyze data to inform product decisions and strategy, ensuring the product remains competitive.
Product development and lifecycle management:
  • Collaborate with engineering and design teams to develop product specifications and ensure timely delivery of high-quality products.
  • Prioritize features, define product requirements, and manage the product backlog
  • Manage the product lifecycle from concept to launch, ensuring deadlines are met and resources are effectively allocated.
  • Develop and execute end-of-life strategies, ensuring smooth transitions, clear customer communication, and effective management of remaining inventory and support obligations.
Cross-functional Collaboration:
  • Ensure effective communication and alignment across all teams involved in the product lifecycle.
Customer Focus:
  • Gather and analyze customer feedback to continuously improve the product and enhance user experience.
  • Act as the voice of the customer within the company, advocating for their needs and ensuring the product meets or exceeds customer expectations.
Performance Monitoring:
  • Track and report on product performance, using data to drive decisions and improvements.
  • Identify key metrics and KPIs to measure the success of the product.
We are ideally looking for someone with the following skills and experience
  • Extensive knowledge of analytical instrumentation requirements for the characterization of antibodies, viral vectors, and non-viral vectors in GMP-regulated environments.
  • Deep understanding of mass photometry target applications and workflows.
  • Adequate experience in managing products for life sciences research in GMP regulated environment
  • Experience of working with or in agile teams
  • Excellent written and verbal communication skills
  • Proven ability to influence cross-functional teams without formal authority
  • Regular travel to customers, conferences or workshops (up to 30%)
  • Personal fit to the company culture - passionate, driven by quality and achieving results, high level of integrity
  • Understanding of mass photometry workflows and products
We know there is no such thing as the perfect candidate and that there is great value in transferrable skills, so please don't feel you have to tick all of the above boxes to apply!

Why work for Refeyn?

Compensation and core benefits
  • We use Radford data to ensure we offer competitive salaries. We anticipate a salary between $110,000 and $140,000 for this role.
  • 25 days PTO per year in addition to 10 paid holidays
  • 5% company match to 401(k)
  • Comprehensive core benefits package including medical, dental, vision, life insurance and more
  • Suite of voluntary benefits including flexible spending accounts, supplemental insurances for accident, critical illness, hospital indemnity, and more

Family Friendly Benefits

Refeyn offers generous parental leave options, depending on your length of service, plus an annual allowance for emergency childcare.

Supporting your Development

All employees receive access to Linkedin Learning which offers thousands of courses to support their personal and professional development. We also run frequent training sessions on both hard and soft skills.

Creating an Engaging Culture

Refeyn has a subsidised weekly lunch for onsite employees and a vibrant social calendar which includes holiday parties and midsummer festivals plus an annual team budget for managers to plan team-building activities.

Values-Led

Refeyn is committed to celebrating each other's differences and creating a dynamic, driven and diverse culture where everyone can flourish. We are proud to have been awarded Committed Status by the Inclusive Employers Standard in 2024 and are working hard to create a safe and empowering environment for all.

We firmly believe that there is great strength in building teams with different voices, experiences, perspectives, and backgrounds so that we can continue to share the team workload and enable our customers to succeed, and we welcome applicants from all sections of society to join us on our mission to transform analytical workflows using the power of light.
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Director, Good Manufacturing Practices & Computer System Validation Quality Assurance

92126 San Diego Country Estates, California IDEAYA Biosciences, Inc.

Posted today

Job Viewed

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Job Description

Non-Solicitation Policy and Notice to Agencies and Recruiters:

IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to We ask that you only email your interest once.

Job Summary

ABOUT IDEAYA:

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

Position Summary:

The Director, GMP & CSV QA is a leadership role responsible for developing and maintaining Good Manufacturing Practices (GMP) and Computer System Validation (CSV) Quality Systems as well as supporting internal and external compliance activities. Direct responsibility, authority, and accountability for the Deviation, Corrective Action/Preventive Action (CAPA), Change Control, and Batch Release Systems. Responsibilities will also include acting as QA liaison to various project teams. The candidate will ensure compliance with regulatory requirements, industry standards, and company policies for the manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). The Director will provide strategic leadership, drive continuous improvement initiatives, provide quality oversight of contract organizations, and ensure the highest standards of product quality and patient safety. This position will report to the Vice President, Quality.

This position is based in our South San Francisco headquarter offices or San Diego office and required to be onsite four days per week per our company policy.

Job Description

What you'll do:

* Develop and implement the global GMP & CSV QA strategy aligned with corporate goals, Ideaya SOPs and global regulatory requirements.
* Ensure compliance with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards.
* Develop procedures and work flows to define key Quality Systems including Deviation, CAPA, Change Control and Document management. Ensure that cGMP departments and Operating units within Ideaya have written procedures to support GxP activities.
* Oversee the development, implementation, and maintenance of GMP QA policies, quality agreements, standard operating procedures, and quality systems processes and workflows to manage quality events.
* Manage and oversee all aspects of GxP quality functions for clinical and commercial products i.e., Lot Release, Quality Systems records (i.e., Deviations, Change Control, Complaints, Audits, Product Quality Review).
* Monitor emerging regulatory trends and ensure proactive adaptation of QA processes.
* Compile, track quality metrics (KPI) on process, product attribute and supplier performance and report to management on a quarterly basis.
* Lead and manage GMP audits programs (internal and external), including manufacturing sites, contract manufacturers and packagers, suppliers, and laboratories.
* Host and support regulatory inspections, ensuring inspection readiness and timely resolution of findings. Represent GMP QA in regulatory inspections, partner audits, and due diligence activities.
* Review and approve audit reports, CAPA plans, and follow-up actions to ensure effective resolution of non-conformance and quality events.
* Lead or oversee the annual product quality review (APQR) process to ensure ongoing evaluation of product quality and compliance.
* Drive continuous improvement initiatives based on key performance indicators (KPIs), APQR findings and trends.
* Identify, assess, and mitigate GMP-related risks across the supply chain (end to end), GMP vendors and manufacturing processes.
* Provide expert guidance on GMP & CSV compliance and escalate critical quality events, nonconformances and compliance issues to cross-functional teams and senior management.
* Collaborate with manufacturing, supply chain, regulatory affairs, and other stakeholders to address quality issues and drive continuous improvement.
* Build, mentor, and lead a high-performing GMP & CSV QA team. Foster a culture of quality, accountability, and collaboration within the team and across the organization.
* Partner with CMC, regulatory affairs, IT and R&D to ensure alignment on quality and compliance objectives.
* Support the development and review of batch records, specifications, test methods, protocols, and other critical documents.
* Oversee the selection, qualification, and ongoing monitoring of all GMP vendors, including contract manufacturers, suppliers, and testing laboratories.
* Ensure vendor compliance with contractual obligations, quality agreements and regulatory requirements.

Requirements:

* Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).
* Minimum of 12 years of experience in the pharmaceutical or biotechnology industry, with at least 8 years in GMP QA or manufacturing quality roles working in a firm with in-house manufacturing.
* Proven track record and relevant industry experience in leading GMP QA functions within a global organization. Flexibility to work in a fast-paced, dynamic environment with evolving priorities.
* Strong knowledge of global GMP & CSV regulations, ICH guidelines, and pharmaceutical manufacturing processes.
* Experience hosting regulatory inspections (e.g., FDA, EMA, PMDA) and managing Ideaya audit programs.
* Exceptional leadership and team-building skills, strong analytical, problem-solving, and decision-making abilities.
* Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels.
* Strategic thinker with a focus on continuous improvement and innovation.
* This role may require occasional travel (up to 20%) for audits, inspections, and meetings.



Preferred Skills:

* Prior supervisory or function management experience is required.

Salary Range: $187,000 - $31,000

At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco or San Diego, California office is 187,000 - 231,000.

The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates' experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.
View Now

Director, Good Manufacturing Practices & Computer System Validation Quality Assurance

94083 South San Francisco, California BioSpace

Posted 3 days ago

Job Viewed

Tap Again To Close

Job Description

Job Details

Non-Solicitation Policy and Notice to Agencies and Recruiters:
IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships . Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to We ask that you only email your interest once.

Job Summary
ABOUT IDEAYA:
IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

Position Summary:
The Director, GMP & CSV QA is a leadership role responsible for developing and maintaining Good Manufacturing Practices (GMP) and Computer System Validation (CSV) Quality Systems as well as supporting internal and external compliance activities. Direct responsibility, authority, and accountability for the Deviation, Corrective Action/Preventive Action (CAPA), Change Control, and Batch Release Systems. Responsibilities will also include acting as QA liaison to various project teams. The candidate will ensure compliance with regulatory requirements, industry standards, and company policies for the manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). The Director will provide strategic leadership, drive continuous improvement initiatives, provide quality oversight of contract organizations, and ensure the highest standards of product quality and patient safety. This position will report to the Vice President, Quality.
This position is based in our South San Francisco headquarter offices or San Diego office and required to be onsite four days per week per our company policy.

Job Description

What you'll do:
  • Develop and implement the global GMP & CSV QA strategy aligned with corporate goals, Ideaya SOPs and global regulatory requirements.
  • Ensure compliance with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards.
  • Develop procedures and work flows to define key Quality Systems including Deviation, CAPA, Change Control and Document management. Ensure that cGMP departments and Operating units within Ideaya have written procedures to support GxP activities.
  • Oversee the development, implementation, and maintenance of GMP QA policies, quality agreements, standard operating procedures, and quality systems processes and workflows to manage quality events.
  • Manage and oversee all aspects of GxP quality functions for clinical and commercial products i.e., Lot Release, Quality Systems records (i.e., Deviations, Change Control, Complaints, Audits, Product Quality Review).
  • Monitor emerging regulatory trends and ensure proactive adaptation of QA processes.
  • Compile, track quality metrics (KPI) on process, product attribute and supplier performance and report to management on a quarterly basis.
  • Lead and manage GMP audits programs (internal and external), including manufacturing sites, contract manufacturers and packagers, suppliers, and laboratories.
  • Host and support regulatory inspections, ensuring inspection readiness and timely resolution of findings. Represent GMP QA in regulatory inspections, partner audits, and due diligence activities.
  • Review and approve audit reports, CAPA plans, and follow-up actions to ensure effective resolution of non-conformance and quality events.
  • Lead or oversee the annual product quality review (APQR) process to ensure ongoing evaluation of product quality and compliance.
  • Drive continuous improvement initiatives based on key performance indicators (KPIs), APQR findings and trends.
  • Identify, assess, and mitigate GMP-related risks across the supply chain (end to end), GMP vendors and manufacturing processes.
  • Provide expert guidance on GMP & CSV compliance and escalate critical quality events, nonconformances and compliance issues to cross-functional teams and senior management.
  • Collaborate with manufacturing, supply chain, regulatory affairs, and other stakeholders to address quality issues and drive continuous improvement.
  • Build, mentor, and lead a high-performing GMP & CSV QA team. Foster a culture of quality, accountability, and collaboration within the team and across the organization.
  • Partner with CMC, regulatory affairs, IT and R&D to ensure alignment on quality and compliance objectives.
  • Support the development and review of batch records, specifications, test methods, protocols, and other critical documents.
  • Oversee the selection, qualification, and ongoing monitoring of all GMP vendors, including contract manufacturers, suppliers, and testing laboratories.
  • Ensure vendor compliance with contractual obligations, quality agreements and regulatory requirements.

Requirements:
  • Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).
  • Minimum of 12 years of experience in the pharmaceutical or biotechnology industry, with at least 8 years in GMP QA or manufacturing quality roles working in a firm with in-house manufacturing.
  • Proven track record and relevant industry experience in leading GMP QA functions within a global organization. Flexibility to work in a fast-paced, dynamic environment with evolving priorities.
  • Strong knowledge of global GMP & CSV regulations, ICH guidelines, and pharmaceutical manufacturing processes.
  • Experience hosting regulatory inspections (e.g., FDA, EMA, PMDA) and managing Ideaya audit programs.
  • Exceptional leadership and team-building skills, strong analytical, problem-solving, and decision-making abilities.
  • Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels.
  • Strategic thinker with a focus on continuous improvement and innovation.
  • This role may require occasional travel (up to 20%) for audits, inspections, and meetings.

Preferred Skills:
  • Prior supervisory or function management experience is required.

Salary Range: $187,000 - $31,000

At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco or San Diego, California office is 187,000 - 231,000.

The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates' experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.
View Now

Director, Good Manufacturing Practices & Computer System Validation Quality Assurance

94083 South San Francisco, California BioSpace, Inc.

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

Job Details

Non-Solicitation Policy and Notice to Agencies and Recruiters:
IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to We ask that you only email your interest once.

Job Summary
About IDEAYA Biosciences:
IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see

Location: South San Francisco, CA.

Position Summary:
We are seeking a Director of Good Manufacturing Practices and Computer System Validation Quality Assurance to join our IDEAYA Quality team. The Director, GMP & CSV QA is a leadership role responsible for developing and maintaining Good Manufacturing Practices (GMP) and Computer System Validation (CSV) Quality Systems as well as supporting internal and external compliance activities. Direct responsibility, authority, and accountability for the Deviation, Corrective Action/Preventive Action (CAPA), Change Control, and Batch Release Systems. Responsibilities will also include acting as QA liaison to various project teams. The candidate will ensure compliance with regulatory requirements, industry standards, and company policies for the manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). The Director will provide strategic leadership, drive continuous improvement initiatives, provide quality oversight of contract organizations, and ensure the highest standards of product quality and patient safety. This position will report to the Vice President, Quality.

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Job Description

What you'll do:
  • Develop and implement the global GMP & CSV QA strategy aligned with corporate goals, Ideaya SOPs and global regulatory requirements.
  • Ensure compliance with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards.
  • Develop procedures and work flows to define key Quality Systems including Deviation, CAPA, Change Control and Document management. Ensure that cGMP departments and Operating units within Ideaya have written procedures to support GxP activities.
  • Oversee the development, implementation, and maintenance of GMP QA policies, quality agreements, standard operating procedures, and quality systems processes and workflows to manage quality events.
  • Manage and oversee all aspects of GxP quality functions for clinical and commercial products i.e., Lot Release, Quality Systems records (i.e., Deviations, Change Control, Complaints, Audits, Product Quality Review).
  • Monitor emerging regulatory trends and ensure proactive adaptation of QA processes.
  • Compile, track quality metrics (KPI) on process, product attribute and supplier performance and report to management on a quarterly basis.
  • Lead and manage GMP audits programs (internal and external), including manufacturing sites, contract manufacturers and packagers, suppliers, and laboratories.
  • Host and support regulatory inspections, ensuring inspection readiness and timely resolution of findings. Represent GMP QA in regulatory inspections, partner audits, and due diligence activities.
  • Review and approve audit reports, CAPA plans, and follow-up actions to ensure effective resolution of non-conformance and quality events.
  • Lead or oversee the annual product quality review (APQR) process to ensure ongoing evaluation of product quality and compliance.
  • Drive continuous improvement initiatives based on key performance indicators (KPIs), APQR findings and trends.
  • Identify, assess, and mitigate GMP-related risks across the supply chain (end to end), GMP vendors and manufacturing processes.
  • Provide expert guidance on GMP & CSV compliance and escalate critical quality events, nonconformances and compliance issues to cross-functional teams and senior management.
  • Collaborate with manufacturing, supply chain, regulatory affairs, and other stakeholders to address quality issues and drive continuous improvement.
  • Build, mentor, and lead a high-performing GMP & CSV QA team. Foster a culture of quality, accountability, and collaboration within the team and across the organization.
  • Partner with CMC, regulatory affairs, IT and R&D to ensure alignment on quality and compliance objectives.
  • Support the development and review of batch records, specifications, test methods, protocols, and other critical documents.
  • Oversee the selection, qualification, and ongoing monitoring of all GMP vendors, including contract manufacturers, suppliers, and testing laboratories.
  • Ensure vendor compliance with contractual obligations, quality agreements and regulatory requirements.
Requirements:
  • Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).
  • Minimum of 12 years of experience in the pharmaceutical or biotechnology industry, with at least 8 years in GMP QA or manufacturing quality roles working in a firm with in-house manufacturing.
  • Proven track record and relevant industry experience in leading GMP QA functions within a global organization. Flexibility to work in a fast-paced, dynamic environment with evolving priorities.
  • Strong knowledge of global GMP & CSV regulations, ICH guidelines, and pharmaceutical manufacturing processes.
  • Experience hosting regulatory inspections (e.g., FDA, EMA, PMDA) and managing Ideaya audit programs.
  • Exceptional leadership and team-building skills, strong analytical, problem-solving, and decision-making abilities.
  • Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels.
  • Strategic thinker with a focus on continuous improvement and innovation.
  • This role may require occasional travel (up to 20%) for audits, inspections, and meetings.
Preferred Skills:
  • Prior supervisory or function management experience is required.


Total Rewards

Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

The expected salary range for the roleof Director, Good Manufacturing Practices & Computer System Validation Quality Assurance is $187,000 - $231,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates' experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite in the office at the Company's facilities for training & meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.
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  40. gavel Legal
  41. sports_soccer Leisure & Sports
  42. inventory_2 Logistics & Warehousing
  43. supervisor_account Management
  44. supervisor_account Management Consultancy
  45. supervisor_account Manufacturing & Production
  46. campaign Marketing
  47. build Mechanical Engineering
  48. perm_media Media & PR
  49. local_hospital Medical
  50. local_hospital Military & Public Safety
  51. local_hospital Mining
  52. medical_services Nursing
  53. local_gas_station Oil & Gas
  54. biotech Pharmaceutical
  55. checklist_rtl Project Management
  56. shopping_bag Purchasing
  57. home_work Real Estate
  58. person_search Recruitment Consultancy
  59. store Retail
  60. point_of_sale Sales
  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
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