Catalent
Director, Quality Assurance Operations
Catalent, Harmans, Maryland, United States, 21077
Director, Quality Assurance Operations
Position Summary
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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 Director, Quality Assurance Operations provides strategic oversight and leadership to QA operations supporting commercial activities including real-time batch record review, QA On the Floor (QA-OTF), deviation support and approval and client QA activities. The incumbent ensures project objectives are met to a high-quality standard and according to commitments while ensuring current Good Manufacturing Practices (cGMPs) compliance for manufacturing of biological product, and compliance to US, EU regulations, and other Boards of Health (BOH) regulations as applicable.
The Role
Outlines and executes department and business objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to staff to ensure success.
Provides strategic oversight and leadership to client representatives to ensure project objectives are met to a high-quality standard and according to commitments.
Directs the real-time batch record review activities to ensure product delivery in compliance with applicable regulatory submissions and approvals within prescribed timelines.
Provides investigation direction, support, and department approvals.
Ensures investigation CAPA actions are clearly defined, effective in resolving the root causes and are implemented timely.
Oversees client-facing personnel supporting cVIT in the roles of Client QA.
Directs QA-OTF activities supporting commercial activities including central services and manufacturing operations.
Facilitates QA support and works closely with other Catalent cross-functional units including Manufacturing, Validation, Facilities Engineering, and Quality Control to assess and resolve quality issues with regard to the facility and products manufactured.
Develops and implements procedures, programs, and policies that support GMP operations and overall compliance strategy.
Work with senior management to initiate new client proposals and projects. This includes analyzing client proposals for resource allocation and QA costs generated by Business Development.
The Candidate
Bachelor's degree in science or related field required (Chemistry, Microbiology or Biology preferred).
10+ years of relevant work experience in pharmaceuticals, preferably biotechnology within a Quality role.
8+ years of leadership experience including performance management.
Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP, EP, JP and other applicable regulations and guidance.
Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish. Exposure to contract manufacturing a plus.
Ability to quickly learn new and novel manufacturing processes supporting new clients.
Ability to self-direct and adapt to changing priorities. Excellent communication and interpersonal skills required.
Ability to work effectively under pressure to meet deadlines.
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
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.
#J-18808-Ljbffr
Position Summary
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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 Director, Quality Assurance Operations provides strategic oversight and leadership to QA operations supporting commercial activities including real-time batch record review, QA On the Floor (QA-OTF), deviation support and approval and client QA activities. The incumbent ensures project objectives are met to a high-quality standard and according to commitments while ensuring current Good Manufacturing Practices (cGMPs) compliance for manufacturing of biological product, and compliance to US, EU regulations, and other Boards of Health (BOH) regulations as applicable.
The Role
Outlines and executes department and business objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to staff to ensure success.
Provides strategic oversight and leadership to client representatives to ensure project objectives are met to a high-quality standard and according to commitments.
Directs the real-time batch record review activities to ensure product delivery in compliance with applicable regulatory submissions and approvals within prescribed timelines.
Provides investigation direction, support, and department approvals.
Ensures investigation CAPA actions are clearly defined, effective in resolving the root causes and are implemented timely.
Oversees client-facing personnel supporting cVIT in the roles of Client QA.
Directs QA-OTF activities supporting commercial activities including central services and manufacturing operations.
Facilitates QA support and works closely with other Catalent cross-functional units including Manufacturing, Validation, Facilities Engineering, and Quality Control to assess and resolve quality issues with regard to the facility and products manufactured.
Develops and implements procedures, programs, and policies that support GMP operations and overall compliance strategy.
Work with senior management to initiate new client proposals and projects. This includes analyzing client proposals for resource allocation and QA costs generated by Business Development.
The Candidate
Bachelor's degree in science or related field required (Chemistry, Microbiology or Biology preferred).
10+ years of relevant work experience in pharmaceuticals, preferably biotechnology within a Quality role.
8+ years of leadership experience including performance management.
Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP, EP, JP and other applicable regulations and guidance.
Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish. Exposure to contract manufacturing a plus.
Ability to quickly learn new and novel manufacturing processes supporting new clients.
Ability to self-direct and adapt to changing priorities. Excellent communication and interpersonal skills required.
Ability to work effectively under pressure to meet deadlines.
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
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.
#J-18808-Ljbffr