Senior Manager of Technical QA (GMP)

Experience, Education and Specialized Knowledge and Skills

• Bachelor’s degree in chemistry, biochemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific disciplines. Higher degree (MS, PhD, PharmD) preferred
• A minimum of 10 years’ experience in the pharmaceutical industry with at least 5 years experience in commercial manufacturing of drug substance and drug product.
• Biologics experience is essential. Working knowledge in analytical laboratory testing is required.
• Experience in the use of e-QMS to effectively execute quality systems such as MasterControl or TrackWise. A strong proficiency in CMC regulatory submissions, with direct experience reviewing IND/IMPD sections, BLA/MAA CMC modules. Strong expertise and experience with GMP manufacturing requirements for clinical biologics
• Demonstrated ability working with and managing CMOs.
• Demonstrated expertise in managing and assessing manufacturing, analytical, validation, facility, and computerized system change controls.
• Experience in designing and implementing quality systems and risk management tools
• Experience supporting US and international health authority inspections
• Strong knowledge of FDA, EMA, MHRA, ICH, PIC/S and international GMP regulations governing biologics manufacturing.
• Working knowledge of process validation, cleaning validation, equipment qualification and computerized systems validation within biologics manufacturing environments.
• Excellent communication skills both oral and written.
• Experience in working independently on multiple programs in a fast-paced environment with and able to balance changing priorities
• Attention to detail, self-motivated with a strong sense of work ethic
• Excellent interpersonal skills and collaborative

Role and Responsibilities

1. 1Responsible for providing sponsor oversight of clinical Contract Manufacturing Organizations (CMO) and Contract Testing Laboratories (CTLs) to support clinical manufacture and testing.
2. 2Responsible for providing sponsor oversight of Contract Testing Laboratories (CTLs) support clinical and commercial product testing, methods, method transfers, method validations, stability, and specifications.
3. 3Partner with Supplier Quality to monitor quality performance metrics for CMOs, CTLs and critical suppliers, ensuring effective management of quality risks and continuous improvement initiatives.
4. 4Maintain the Annual Product Quality Review process, including trend analysis, product quality assessments, process performance evaluation and management review reporting.
5. 5Collaborate with MSAT and Technical Operations teams for Change Controls of process development, technology transfer, scale-up activities, and other manufacturing and analytical changes and provide quality oversight for the Change Control program while ensuring appropriate impact assessments, risk evaluations, implementation plans and effectiveness verification. Schedule and lead weekly Change Control meetings.
6. 6Provide quality oversight and approval of process validation strategies, continued process verification programs, comparability protocols and lifecycle validation activities.
7. 7Provide quality oversight and approval of technology transfer activities between development, clinical and commercial manufacturing facilities.
8. 8Support GMP inspection readiness activities for Summit and external manufacturing partners and provide quality leadership during health authority inspections, supplier audits, and regulatory interactions.
9. 9Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions as appropriate
10. 10Serve as GMP quality for CMC regulatory submissions, including IND, IMPD, BLA/MAA modules and ensure all CMC documentation is accurate.
11. 11Facilitate quality risk management activities using ICH Q9 principles including risk assessments, risk mitigation strategies, and effectiveness monitoring.
12. 12Review existing policies and procedures, and develop new and enhanced policies that ensure compliance with regulations
13. 13Write, revise, review and/or approve SOPs, controlled documents to ensure compliance with all applicable regulations
14. 14Drive cross-functional collaboration and alignment with other departments, and stakeholders to achieve quality and compliance objectives
15. 15Drive continuous improvement of the Quality Management System and promote best practices across the organization.
16. 16Ensure quality issues are effectively escalated, investigated, documented and resolved in a timely and compliant manner.
17. 17Develop and monitor key quality metrics and trends to proactively identify compliance risks and drive continuous improvement.