Senior Manager, Commercial GMP Quality

The Senior Quality Manager, Commercial Quality reports to the Director Quality Assurance and is responsible for Quality Operations. Primary responsibility includes quality oversight and compliance activities related to the cGMP manufacture and release of commercial products. The successful candidate will be responsible for interfacing with global contract development manufacturing organizations (CDMOs) and providing quality approval of deviations, CAPAs, and change controls while ensuring activities are performed according to applicable guidelines and regulations. The Senior Quality Manager will have responsibility for commercial batch disposition and ongoing continuous improvement initiatives.

PRINCIPAL DUTIES:

• Quality Operations and Batch Disposition:

• Provides GMP Quality Assurance oversight of clinical products manufactured at Contract Development Manufacturing Organizations (CDMOs).
• Responsible for clinical product batch disposition
• Provides leadership for significant deviation events or failure investigations at CDMOs and contract test labs.
• Leads implementation of corrective actions and quality system improvements.
• Oversees the investigation and resolution of deviations, CAPAs, and product quality complaints, ensuring timely closure and compliance with regulatory standards.
• Performs external and internal QA audits as required.
• Leads QA evaluations of clinical product quality at Material Review Board and Quality Management Review.
• Establishes collaborative working relationships with other staff in Technical Operations.
• Identifies quality issues and communicates to manager as appropriate.
• Serves as the Quality representative on cross-functional and multi-site teams as required.

• Supplier Quality Systems and Compliance:

• Leads the Supplier Quality oversight for clinical GMP operations, ensuring timely and appropriate vendor qualification, audits, and ongoing oversight.
• Ensures effective quality agreements with GMP vendors and oversee GMP quality operations at all facilities for clinical products.

• Regulatory and Risk Management:

• Utilizes Quality Risk Management in the evaluation of deviations and change controls including changes to the clinical product supply chain.
• Reviews relevant sections of regulatory submissions, including IND, IMPD, BLA, and NDA documents.

• Continuous Improvement and Innovation:

• Drives continuous improvement of quality processes, systems, and operations, seeking opportunities for innovation and efficiency.
• Promotes a quality mindset, ensuring that all activities align with the highest standards of quality and compliance.
• Leads initiatives to enhance the effectiveness of the QMS, including change control, deviation management, and CAPA systems.

REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):

Education & Experience:

• A minimum of seven (7) years GMP QA experience in the Biotech/Pharmaceutical industry or an equivalent combination of education and experience.

• A BS degree in a scientific discipline is required.

• Extensive knowledge of GMP guidelines, regulatory requirements, and industry best practices. Demonstrated knowledge of international regulatory requirements for biotech products and experience in disposition of biotech products to multiple jurisdictions.

• Proven experience in Quality Operations and managing quality oversight of CDMOs and contract test labs.

Competencies, Skills and Knowledge:

• Experience with large molecule biologics and small molecules required.

• Prior experience in batch disposition, deviations, CAPA’s.

• Experience with both commercial and clinical products preferred.

• Excellent understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations.

• Strong investigation and root cause analytical skills.

• Demonstrated strong ability in problem solving, strong understanding of cGMPs, excellent interpersonal skills and the ability to prioritize multiple tasks.

• Ability to work both independently and collaboratively in a team structure across all levels of the business.

• Demonstrated strong organizational, interpersonal and communication skills to plan and accomplish goals with competing priorities.

• Knowledge and experience in interpretation of regulations, guidelines, and industry standards.

• Previous experience with inspection management preferred.

• Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions, actions and resolutions