8,349 Director Of Quality jobs in the United States

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you'll love working at Axogen:

* Friendly, open, and fun team culture that values unique perspectives
* Company-wide dedication to profoundly impacting patients' lives
* Comprehensive, high-quality benefits package effective on date of hire
* Educational assistance available for all employees
* Matching 401(k) retirement plan
* Paid holidays, including floating holidays, to be used at your discretion
* Employee Stock Purchase Plan
* Referral incentive program

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Director, Quality Control

The Quality Control Director is responsible for the oversight of all Quality Control Laboratory functions, activities, and personnel at the Axogen Processing Center (APC) and associated contract laboratories. This includes all analyses done on donor tissue, raw materials, and in process, product release, environmental monitoring, and commercial product stability samples. Additionally, the Quality Control Director builds and maintains collaborative work relationships with APC and company Operations, Quality Assurance, Finance, and Regulatory leaders to drive cross-functional planning and decision-making regarding Quality Control Laboratory operations and process improvement.

Requirements of the Director, Quality Control

* Bachelor's degree in chemistry, biology or other sciences related field.
* Minimum of ten (10) years of relevant industry experience.
* Minimum of six (6) years QC supervisory experience (hiring and coaching associates and supervisors).
* Strong laboratory skills (microbiology, histology, and incoming quality control).
* Experience in the validation and transfer of analytical methods from/to R&D and/or contract laboratories.
* Experience working in sterile processing environment.
* Experience working in an FDA or AATB regulated industry.
* Strong skills in communicating technical and scientific information.
* Strong organizational and problem-solving skills.

Responsibilities of the Director, Quality Control

The specific duties of the Director, Quality Control include but are not limited to:

* Leads the APC Quality Control Laboratory, including organizational design, operating budget, personnel recruiting, and employee technical and behavioral competency development and training.
* Collaborates across the company representing the Quality Control Laboratory, engaging with stakeholders and business partners in both a technical and management leadership capacity.
* Ensures the Quality Control support strategy for the APC site is technically sound and in alignment with business objectives and quality/regulatory requirements. Owns key laboratory QMS processes, including deviations, CAPA actions, implementing compendia changes, technical problem solving, and monitoring operational results via trend analyses.
* Creates an environment with strong team spirit, timely and effective communication, sense of urgency and high motivation, and inspires Quality Control team members to achieve short and long-term goals.
* Sets an expectation of achieving outcomes, continuous learning, and shared accountability; champions a mindset of inclusivity, speaking up, and coaching others.
* Takes proactive measures to promote a positive safety culture and ensure all applicable safety, health and environmental requirements are met in accordance with company policies.
* Embodies Lean principles and methodologies and promotes a continuous improvement culture throughout the Quality Control organization by encouraging experimentation and learning.
* Provides laboratory oversite regarding Out of Specification results and associated investigations, both with internal and external contract testing laboratories.
* Represents the Quality Control Lab during regulatory inspections and internal audits.
* Performs all other duties as assigned.

Location

913 Industrial Drive Place, Vandalia, OH 45377

#LI-AC1

Benefits/Compensation

This position is eligible for an annual bonus.

Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.

Salary Range

$163,910-$204,887 USD

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.

Director, Quality Control

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a private company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's.

The Director of Quality Control is responsible for all activities within the QC department. The QC team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the Catalent Madison Biologics facility. The QC team is comprised of the following groups: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation and Sample Management.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role

• Manage QC resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports.'
• Interact and communicate with customers to ensure expectations are established, agreed to, and achieved.
• Engage actively with Project Management and other department functions to ensure that CGMP programs are properly supported in order to achieve expectations; maintain effective and professional communication between all parties, including the customer.
• Develop a team of quality professionals to support quality systems and investigation management objectives and ensure continual quality improvement.
• Accountable for all activities within the Quality Control department: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation, Sample Management as well as other functions (which include: technical data review, training, instrument maintenance, lead investigator, LIMS).
• Effectively communicates Quality vision and expectations across site, including periodic site wide GMP training in addition to focused trainings.
• Drives systemic process changes as a result of Deviations/Complaints and other quality trends.
• Helps define department objectives to align with BU goals. Regularly communicates to team, department and company about department and company priorities. Monitors and evaluates social, fiscal, and political trends that affect the plan.
• Other duties as assigned.

The Candidate

• Doctorate Degree in STEM discipline with 8+ years related experience, OR Master's Degree in STEM discipline with 12+ years related experience, OR Bachelor's Degree in STEM discipline with 15+ years related experience.
• 6+ years of leadership experience required.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.
• Understand the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances.
• Ability to communicate complex technical information to non-technical audiences.
• Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution.
• Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process.
• Experienced in all aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Dynamic, fast-paced work environment
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Director, Quality Control

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a private company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's.

The Director of Quality Control is responsible for all activities within the QC department. The QC team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the Catalent Madison Biologics facility. The QC team is comprised of the following groups: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation and Sample Management.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role

* Manage QC resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports.'


* Interact and communicate with customers to ensure expectations are established, agreed to, and achieved.


* Engage actively with Project Management and other department functions to ensure that CGMP programs are properly supported in order to achieve expectations; maintain effective and professional communication between all parties, including the customer.


* Develop a team of quality professionals to support quality systems and investigation management objectives and ensure continual quality improvement.


* Accountable for all activities within the Quality Control department: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation, Sample Management as well as other functions (which include: technical data review, training, instrument maintenance, lead investigator, LIMS).


* Effectively communicates Quality vision and expectations across site, including periodic site wide GMP training in addition to focused trainings.


* Drives systemic process changes as a result of Deviations/Complaints and other quality trends.


* Helps define department objectives to align with BU goals. Regularly communicates to team, department and company about department and company priorities. Monitors and evaluates social, fiscal, and political trends that affect the plan.


* Other duties as assigned.



The Candidate

* Doctorate Degree in STEM discipline with 8+ years related experience, OR Master's Degree in STEM discipline with 12+ years related experience, OR Bachelor's Degree in STEM discipline with 15+ years related experience.


* 6+ years of leadership experience required.


* Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.


* Understand the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances.


* Ability to communicate complex technical information to non-technical audiences.


* Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution.


* Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process.


* Experienced in all aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.



Why You Should Join Catalent

* Defined career path and annual performance review and feedback process


* Diverse, inclusive culture


* Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives


* Dynamic, fast-paced work environment


* Community engagement and green initiatives


* Generous 401K match and Paid Time Off accrual


* Medical, dental and vision benefits effective day one of employment


* Tuition Reimbursement



Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

**Director, Quality Control**

**Position Summary**

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a private company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's.

The Director of Quality Control is responsible for all activities within the QC department. The QC team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the Catalent Madison Biologics facility. The QC team is comprised of the following groups: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation and Sample Management.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

**The Role**

+ Manage QC resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports.'

+ Interact and communicate with customers to ensure expectations are established, agreed to, and achieved.

+ Engage actively with Project Management and other department functions to ensure that CGMP programs are properly supported in order to achieve expectations; maintain effective and professional communication between all parties, including the customer.

+ Develop a team of quality professionals to support quality systems and investigation management objectives and ensure continual quality improvement.

+ Accountable for all activities within the Quality Control department: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation, Sample Management as well as other functions (which include: technical data review, training, instrument maintenance, lead investigator, LIMS).

+ Effectively communicates Quality vision and expectations across site, including periodic site wide GMP training in addition to focused trainings.

+ Drives systemic process changes as a result of Deviations/Complaints and other quality trends.

+ Helps define department objectives to align with BU goals. Regularly communicates to team, department and company about department and company priorities. Monitors and evaluates social, fiscal, and political trends that affect the plan.

+ Other duties as assigned.

**The Candidate**

+ Doctorate Degree in STEM discipline with 8+ years related experience, OR Master's Degree in STEM discipline with 12+ years related experience, OR Bachelor's Degree in STEM discipline with 15+ years related experience.

+ 6+ years of leadership experience required.

+ Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.

+ Understand the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances.

+ Ability to communicate complex technical information to non-technical audiences.

+ Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution.

+ Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process.

+ Experienced in all aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.

**Why You Should Join Catalent**

+ Defined career path and annual performance review and feedback process

+ Diverse, inclusive culture

+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

+ Dynamic, fast-paced work environment

+ Community engagement and green initiatives

+ Generous 401K match and Paid Time Off accrual

+ Medical, dental and vision benefits effective day one of employment

+ Tuition Reimbursement

**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers ( to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE ( .

**Director, Quality Control**
**Position Summary**
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a private company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's.
The Director of Quality Control is responsible for all activities within the QC department. The QC team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the Catalent Madison Biologics facility. The QC team is comprised of the following groups: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation and Sample Management.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
**The Role**
+ Manage QC resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports.'
+ Interact and communicate with customers to ensure expectations are established, agreed to, and achieved.
+ Engage actively with Project Management and other department functions to ensure that CGMP programs are properly supported in order to achieve expectations; maintain effective and professional communication between all parties, including the customer.
+ Develop a team of quality professionals to support quality systems and investigation management objectives and ensure continual quality improvement.
+ Accountable for all activities within the Quality Control department: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation, Sample Management as well as other functions (which include: technical data review, training, instrument maintenance, lead investigator, LIMS).
+ Effectively communicates Quality vision and expectations across site, including periodic site wide GMP training in addition to focused trainings.
+ Drives systemic process changes as a result of Deviations/Complaints and other quality trends.
+ Helps define department objectives to align with BU goals. Regularly communicates to team, department and company about department and company priorities. Monitors and evaluates social, fiscal, and political trends that affect the plan.
+ Other duties as assigned.
**The Candidate**
+ Doctorate Degree in STEM discipline with 8+ years related experience, OR Master's Degree in STEM discipline with 12+ years related experience, OR Bachelor's Degree in STEM discipline with 15+ years related experience.
+ 6+ years of leadership experience required.
+ Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.
+ Understand the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances.
+ Ability to communicate complex technical information to non-technical audiences.
+ Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution.
+ Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process.
+ Experienced in all aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.
**Why You Should Join Catalent**
+ Defined career path and annual performance review and feedback process
+ Diverse, inclusive culture
+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
+ Dynamic, fast-paced work environment
+ Community engagement and green initiatives
+ Generous 401K match and Paid Time Off accrual
+ Medical, dental and vision benefits effective day one of employment
+ Tuition Reimbursement
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Quality Control Director  

This role provides administrative and technical leadership to Quality Control teams overseeing Virology, Immunochemistry, Microbiology, and other key areas. The Director will manage quality control operations, ensuring compliance with corporate and regulatory requirements while supporting internal departments and external customers.  

Your Responsibilities:   

• Provide quality oversight to the department and site regarding compliant documentation approaches involving change management, good documentation practices, sample control, laboratory systems and laboratory investigations. 

• Assist with audit responses and completion of assigned CAPAs by target due dates.  

• Develop and maintain standard operating procedures (SOP) and training for sample control and accountability. 

• Proactively identify and mitigate risks to quality control processes, ensure the ongoing maintenance and improvement of validated test methods, and implement improvements ensuring a high functioning and efficient laboratory.  

• Oversee quality control investigations by ensuring employee training, reviewing reports for compliance, and facilitating cross-functional root cause analysis and CAPA development. 

What You Need to Succeed (minimum qualifications):  

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals or a related field with 10 years of relevant experience.  

• At least 5 years' experience in people leadership. 

• Experience in a regulated pharmaceutical/vaccine manufacturing environment.

• Well versed in regulatory requirements, inclusive of cGMP/GLP. 

What Will Give You a Competitive Edge (preferred qualifications):  

• Ability to plan, schedule, organize, prioritize, and coordinate project activities. 

• Demonstrates proficiency in lean/5S/six sigma methodologies 

• Good knowledge of statistics, databases, and quality principles. 

Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!    

Elanco Benefits and Perks:   

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:  

• Multiple relocation packages  

• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)  

• 8-week parental leave  

• 9 Employee Resource Groups  

• Annual bonus offering  

• Flexible work arrangements  

• Up to 6% 401K matching 

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses
worldwide. Gilead Sciences is currently seeking an Director level position to be a Product Quality Lead (PQL), Quality Assurance, in the Pharmaceutical Development and Manufacturing (PDM) organization. The PQL is a strategic matrixed leadership position responsible for end-to-end product quality strategy. The PQL will serve as an individual contributor and as the primary Quality representative on the PDM Product Strategy Team(s), and lead of the Product Quality Team. The candidate should have a scientific and technical understanding of drug development and commercialization and be able to provide effective quality oversight and feedback for their assigned program(s) by liaising between the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC, and the wider PDM Quality organization. The successful candidate must have experience in a biotechnology and pharmaceutical development environment and strong knowledge of cGMP quality systems. **This is an on-site position based at our Foster City headquarters.**
***Prior Quality leadership and technical management experience in development and/or commercial programs.***
**Job Functions:**
+ Accountable for end-to-end quality compliance of the assigned product/program, which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log.
+ Serve as the primary Quality representative in the PDM meeting.
+ Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones.
+ Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified, mitigated and, if necessary, escalated in a timely manner.
+ Review and approve the strategy for change control(s) impacting the product/program lifecycle.
+ Provide technical oversight of Major and/or Critical Deviations, CAPAs, Biological Product Deviation and Complaints.
+ Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with regulatory communications as needed (e.g. responses to agency information requests, the Notified Body Option).
+ Provide oversight for changes to drug substance and drug product CMC details.
+ Accountable for PAI/PLI readiness and supports Gilead PAI/PLI inspection preparation efforts and post-PAI/PLI follow up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead Sites.
+ Support drug substance and drug product technology transfer, and new product launches.
+ Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products.
+ Accountable for medical device/ combination product quality compliance: engage/liaise with medical device product engineering, development, and quality teams.
+ Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes).
+ Perform work that requires independent decision making and the exercise of independent judgment.
+ Serve as the delegate for Pillar Lead, as needed, for meeting and decision making.
**Knowledge, Experience and Skills:**
+ In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally.
+ Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles.
+ In-depth knowledge in Global requirements/standards for product registration and life-cycle management of product quality.
+ Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product.
+ Skilled at managing multiple projects and timelines and to facilitate meetings.
+ In-depth understanding and execution of Quality Risk Management.
+ Ability to track and follow up on actions.
+ Excellent in verbal, written and interpersonal communication skills.
+ Ability to work in a team-oriented approach to address complex issues in a scientifically sound and compliant way.
+ Ability to lead and influence a matrix-based cross-functional team.
+ Critical and strategic thinking skills and ability to provide pragmatic, risk-based, and phase appropriate guidance and decision-making even when quality and compliance requirements are not well-defined.
+ Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product
**Basic Qualifications:**
+ 12+ years of relevant experience and a Bachelors degree in science or related fields;
OR
+ 10+ years of relevant experience and an advanced science degree such as MS, MD,
OR
+ 8+ years of relevant experience and a PharmD, PhD, in science or related fields
OR
+ 8+ years of relevant experience and advanced business degree such as an MBA
**Preferred Qualifications:**
+ 15+ years of relevant experience and a Bachelors degree in science or related fields;
+ Demonstrated experience and knowledge in quality assurance in a highly regulated manufacturing environment.
+ Direct experience with regulatory health authority submissions (e.g. IND, NDA, BLA, MAA) and/or inspections.
+ Prior Quality leadership and technical management experience in development and/or commercial programs.
**People Leader Accountabilities** **:**
+ Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the
+ way they manage their teams.
+ Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current
+ performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and
+ realize their purpose.
+ Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding
+ them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $210,375.00 - $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION ( environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

**Responsibilities**
**Position Summary:**
This position is responsible for the design, coordination, implementation and management of the Performance Improvement (PI) plan and identifies opportunities for improved patient care, incorporate evidence-based practices, and improved patient outcomes.
Provides leadership in defining, implementing and integrating quality, safety, service and efficiency strategies into the plans, policies, and organizational processes that affect the organization's operations and strategic direction.
**Qualifications**
**Education and Experience:**
+ Minimum of five (5) years of progressive management responsibility in a health care setting, two (2) of which is related to managing an acute care organization's Quality Improvement Program.
+ Bachelor's degree in a healthcare-related field or five (5) years of related job or industry experience in lieu of a degree.
+ Minimum of two (2) years of clinical, patient care experience or equivalent.
**Licensure:**
+ Current State License in a clinical field.
+ Five (5) years' experience in Quality Management can be used in lieu of state license.
+ Certified Professional in Healthcare Quality (CPHQ), or Healthcare Quality and Management Certification (HCQM), or Certificate of Professional Healthcare Quality and Patient Safety (CPQPS) within2 years of employment is required.
**Overview**
Dignity Health Sierra Nevada Memorial Hospital is a 104-bed not-for-profit hospital located in Grass Valley, California. The hospital has been providing compassionate and quality health care to residents and visitors of western Nevada County since 1958. As an affiliate of the nationally recognized Dignity Health system, we ensure our patients receive the highest standard of health care and have access to important regional resources throughout the system, including the Dignity Health Heart & Vascular Institute, the Dignity Health Neurological Institute of Northern California and the Dignity Health Cancer Institute of Greater Sacramento. With 765 employees, 101 active medical staff and 21 Emergency Department beds, Sierra Nevada Memorial Hospital continually implements and upgrades its technology and recruits employees who understand the vital importance of kindness and compassion in the healing process.
One Community. One Mission. One California ( Range**
$66.26 - $98.56 /hour
We are an equal opportunity/affirmative action employer.

**Responsibilities**
**Position Summary:**
An amazing opportunity has just opened up for a Director of Quality based at French Hospital Medical Center, a 98 bed hospital located in San Luis Obispo. Come bask in 315 days of sunshine along the beautiful Central Coast of California, enjoy the many vineyards in the heart of wine-country, shop the local farmer's market, and so much more!
In this role, you will design, coordinate, implement and manage the Performance Improvement (PI) plan and identify opportunities to implement evidence-based practices to improve patient care and patient outcomes. You will provide leadership in defining, implementing and integrating quality, safety, service and efficiency strategies into the plans, policies, and organizational processes that affect the organization's operations and strategic direction.
If you are committed to social justice, health equity, and desire to help shape healthcare in new, innovative ways, you belong with us.
Benefits and offerings for this position include (plus much more!):
+ Relocation assistance.
+ Annual performance-based bonus program.
+ Annual employer contribution to retirement program (no employee contribution needed).
+ Medical benefits for the employee at no payroll deduction.
+ 23 days PTO accrued annually.
+ 12 days Sick Leave accrued annually.
**Qualifications**
**Required Education and Experience:**
+ Bachelor's degree in a healthcare-related field required, or five (5) years of related job or industry experience in lieu of degree.
+ Minimum of five (5) years of progressive management responsibility in a health care setting, two (2) of which is related to managing an acute care organization's Quality Improvement Program, required.
+ Minimum of two (2) years of clinical, patient care experience or equivalent required.
**Required Licensure:**
+ Current State License in a clinical field required. Five (5) years' experience in Quality Management can be used in lieu of state license.
+ Certified Professional in Healthcare Quality (CPHQ), or Healthcare Quality and Management Certification (HCQM), or Certificate of Professional Healthcare Quality and Patient Safety (CPQPS) within 2 years of employment is required.
**Required Special Skills and Training:**
+ Knowledge of quality management methods, tools, and techniques and ability to create and support an environment that meets the quality goals of the organization.
+ Knowledge of federal, state and local healthcare related laws and regulations; ability to comply with these in healthcare practices and activities.
+ Experience developing and implementing clinical, service and operational process improvement initiatives, both small and large scale.
+ Knowledge and expertise in specific performance improvement/CQI methodologies (e.g., Six Sigma, LEAN).
+ Current knowledge of accreditation and regulatory requirements for acute and ambulatory care services (e.g. state, federal, local regulations; Joint Commission, etc.).
+ Experience with the event reporting process, root cause analyses, and event investigation/review.
+ Experience with patient compliant/grievance investigations and prompt resolution.
+ Ability to manage collaboratively and coaches others to achieve optimal performance; delegate effectively; praise/reward contributions; define clear roles and responsibilities; set goals and lead initiatives; adjust plans as necessary.
+ Ability to anticipate, recognize, and deal effectively with existing or potential conflicts at the individual, group, or situation level; ability to apply this understanding appropriately to diverse situations.
+ Ability to identify opportunities and take action to build strategic relationships between one's area and other areas,
#LI-DH
**Overview**
French Hospital Medical Center located in San Luis Obispo California has been named one of the Nation's 100 Top Hospitals by Truven Health Analytics and is rated among the top hospitals in the nation for cardiac orthopedic and GI services. French Hospital has achieved the prestigious designation as a Primary Stroke Center by the Joint Commission. The Copeland Forbes and Rossi Cardiac Care Center provides the latest innovative cardiac and imaging technology. The hospital is also home to the unique Hearst Cancer Resource Center offering free education resources and support to cancer patients and their families. French Hospital Medical Center is a part of Dignity Health's Southern California Division and is a member of CommonSpirit Health the largest not-for-profit health care system in the nation boasting an integrated network of top quality hospitals with physicians from the most prestigious medical schools and comprehensive outpatient services - all recognized for quality safety and service. Each hospital is supported by an active philanthropic Foundation to help meet the growing health care needs of our communities. To learn more go here ( .
One Community. One Mission. One California. ( Range**
$66.26 - $98.56 /hour
We are an equal opportunity/affirmative action employer.