10,264 Quality Director jobs in the United States

We are seeking a full time, Quality Control (QC) Director to lead as an architect, influencer, mentor, and manager as a part of Critical Mass' innovative studio, ArtBot. The ArtBot Studio's cutting-edge creative content automation service and content production teams continue growing rapidly and require a results-driven leader to build upon our quality standards and scale QC to serve more clients globally.

The team you lead provides the creative quality assurances for all content funneling through the system, including the final visual, typographical, and grammatical approvals. You will provide practical leadership for a team of quality control leads and specialists who do the QC planning, collaboration, and execution across all clients in our content automation ecosystem. You will direct your team to deliver exemplary quality standards.

Your professional and structured leadership approach to QC reflects the culture, service, and capabilities of ArtBot as an essential part of its foundational growth and future success.

You understand that automation and innovation, especially with the use of the latest AI tools, are fundamental to the QC practice. Your ability to provide leadership and guidance on how to scale the work your team does is essential to provide fast and accurate QC support to our clients.

You are an excellent communicator who works closely with your internal team of specialists, other ArtBot leaders, and account teams to ensure your practice is delivering on its promise. Mitigating risks and managing the QC practice can be challenging, but your organizational and interpersonal skills are up to the test.

You're a self-starter who is engaged and bringing QC into all applicable aspects of a project, from beginning to end. You apply your Quality Control skills to production outputs large and small including video executions, mobile applications, HTML banners, and digital products. You are excited by the fast pace of advertising and work to support the team.

Job Location: Costa Rica

You will:

• Direct the QC practice and your team of QC leads & specialists.
• Work closely with other discipline directors to establish a next-gen cohesive approach to the end-to-end workflow of intelligent content production.
• Spearhead requirement gathering and risk analysis by enforcing and improving the Quality Control workflow across clients.
• Understand the role of QC Specialists in their work; able to support, step-in, and provide mentorship when needed.
• Plan, scope, and estimate QC program efforts.
• Evaluate, maintain, and administer QC testing tools.
• Monitor production compliance to provided standards and guidelines.
• Recommend talent, negotiating, and hiring contract crew/vendors.

You have:

• Advanced English level (B2+/C1)
• 7+ years leading QC teams in an advertising/creative agency environment.
• Track record of improving efficiencies through process optimization.
• Experience with quality management systems and tools such as AI.
• Possess a deep knowledge of various media specs and best-practices.
• Experience evaluating and adopting new technologies into workflow.
• A pragmatic approach to solving problems.
• Exceptional communication & management skills.
• An appreciation and keen eye for design principles and strong attention to detail.

The Talent Team at Critical Mass is focused on ensuring we provide the best training, mentorship, and employee experience possible! CM new hires & employees are the future of our organization, and we want to set you up for long-term success. In an effort to do so, we expect our team to work from an office an 5 days a week. The ask stems from our want to:

• Strengthen opportunity for continuous learning
• Improve collaboration and team relationships.
• Increase employee engagement

We understand that not everyone may feel comfortable with this expectation, so we ask that you please let us know immediately if there are any concerns so we can help navigate accordingly.

Critical Mass is an equal opportunity employer.

The Critical Mass Talent Acquisition team will only communicate from email addresses that use the URLs criticalmass.com and us.greenhouse-mail.io. We will not use apps such as Facebook Messenger, WhatsApp, or Google Hangouts for communicating with you. We will never ask you to send us money, technology, or anything else to work for our company. If you believe you are the victim of a scam, please review your local government consumer protections guidance and reach out to them directly.

If U.S. based: Canada based: U.K. based: Costa Rica based:

We are seeking a full time, Quality Control (QC) Director to lead as an architect, influencer, mentor, and manager as a part of Critical Mass' innovative studio, ArtBot. The ArtBot Studio's cutting-edge creative content automation service and content production teams continue growing rapidly and require a results-driven leader to build upon our quality standards and scale QC to serve more clients globally.

The team you lead provides the creative quality assurances for all content funneling through the system, including the final visual, typographical, and grammatical approvals. You will provide practical leadership for a team of quality control leads and specialists who do the QC planning, collaboration, and execution across all clients in our content automation ecosystem. You will direct your team to deliver exemplary quality standards.

Your professional and structured leadership approach to QC reflects the culture, service, and capabilities of ArtBot as an essential part of its foundational growth and future success.

You understand that automation and innovation, especially with the use of the latest AI tools, are fundamental to the QC practice. Your ability to provide leadership and guidance on how to scale the work your team does is essential to provide fast and accurate QC support to our clients.

You are an excellent communicator who works closely with your internal team of specialists, other ArtBot leaders, and account teams to ensure your practice is delivering on its promise. Mitigating risks and managing the QC practice can be challenging, but your organizational and interpersonal skills are up to the test.

You're a self-starter who is engaged and bringing QC into all applicable aspects of a project, from beginning to end. You apply your Quality Control skills to production outputs large and small including video executions, mobile applications, HTML banners, and digital products. You are excited by the fast pace of advertising and work to support the team.

Job Location: Costa Rica

You will:

* Direct the QC practice and your team of QC leads & specialists.
* Work closely with other discipline directors to establish a next-gen cohesive approach to the end-to-end workflow of intelligent content production.
* Spearhead requirement gathering and risk analysis by enforcing and improving the Quality Control workflow across clients.
* Understand the role of QC Specialists in their work; able to support, step-in, and provide mentorship when needed.
* Plan, scope, and estimate QC program efforts.
* Evaluate, maintain, and administer QC testing tools.
* Monitor production compliance to provided standards and guidelines.
* Recommend talent, negotiating, and hiring contract crew/vendors.

You have:

* Advanced English level (B2+/C1)
* 7+ years leading QC teams in an advertising/creative agency environment.
* Track record of improving efficiencies through process optimization.
* Experience with quality management systems and tools such as AI.
* Possess a deep knowledge of various media specs and best-practices.
* Experience evaluating and adopting new technologies into workflow.
* A pragmatic approach to solving problems.
* Exceptional communication & management skills.
* An appreciation and keen eye for design principles and strong attention to detail.

The Talent Team at Critical Mass is focused on ensuring we provide the best training, mentorship, and employee experience possible! CM new hires & employees are the future of our organization, and we want to set you up for long-term success. In an effort to do so, we expect our team to work from an office an 5 days a week. The ask stems from our want to:

* Strengthen opportunity for continuous learning
* Improve collaboration and team relationships.
* Increase employee engagement

We understand that not everyone may feel comfortable with this expectation, so we ask that you please let us know immediately if there are any concerns so we can help navigate accordingly.

Critical Mass is an equal opportunity employer.

The Critical Mass Talent Acquisition team will only communicate from email addresses that use the URLs criticalmass.com and us.greenhouse-mail.io. We will not use apps such as Facebook Messenger, WhatsApp, or Google Hangouts for communicating with you. We will never ask you to send us money, technology, or anything else to work for our company. If you believe you are the victim of a scam, please review your local government consumer protections guidance and reach out to them directly.

If U.S. based: Canada based: U.K. based: Costa Rica based:

The Position

The purpose of this position within the Quality and Compliance department is to lead Quality Control (QC) Laboratory consisting of analytical, microbial, stability, reference standard quality control. This includes the establishment and optimization of processes, procedures, analytical methods, and ensuring our Quality Control (QC) align with business strategy and needs. Functions as the GMP laboratory testing technical consultant to QC staff, business operations per strategic business needs.

Responsibilities

* Setting strategy, planning, coordinating, directing, coaching, developing, hiring, and planning the resources, facilities and budgets to manage QC laboratory including setting of vision and strategy, develop and manage operating budgets, management of technical employees, project management, and unit operational management.
* Apply scientific and technological expertise to the validation and optimization of analytical techniques for the identification and characterization of molecules oligo- and polynucleotides and raw materials in cGMP compliant laboratories. Apply extensive advanced scientific knowledge to design and manage multi-disciplinary projects.
* Provide leadership in product testing and Quality System to support overall business operations. Responsible for site processes and procedures related to Quality Control laboratory to ensure product quality and compliance.
* Provide technical leadership in a multidisciplinary environment to ensure activities are on track per business needs and established timeline. Serves as an expert in technical/functional areas.
* Apply advanced technical writing skills to prepare project protocols and reports to support product registration and/or business needs. Technical Reports and Procedural Documents (SOPs, Wis, Test Methods, Policies, Forms, ).
* Develop, negotiate, finalize timelines and cost estimates for projects and/or service contracts to support business operations and/or external partner's needs.
* Represent QC function during 3rd party, QP, and regulatory inspections at Verona, WI facility.
* Hiring and development of QC department staff at the Verona, WI
* Other duties consistent with the position as assigned from time to time.

Requirements:

* Master's Degree
* 10 years of experience in a GxP pharmaceutical/biotech company, contract manufacturing organization, or contract research
* 5 years of experience Directing QC laboratory in cGMP facility.
* Extensive knowledge of GMP and GDP regulations, as well as ICH/FDA guidance documents, including experience with development of applicable compliance programs. Knowledge of GLP/GCP regulations
* Understanding of document control requirements in a FDA regulated
* Competent knowledge of and ability to use Microsoft Word and Excel
* Ability for occasional business
* Strong people leadership skills.
* Solid understanding of financials and budgetary management experience.
* Knowledge and understanding of operation of product quality control lab, product quality control requirement and system.
* Shows broad understanding of the issues relevant to the technical/science and business

Preferred:

* Doctorate degree

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