Senior Manager of Technical QA (GMP)

The role

The Senior Manager of Technical QA (GMP) provides GMP quality oversight across the product lifecycle for an oncology portfolio. This role supports process validation, technology transfer, and change management while serving as the primary quality interface between internal teams and external manufacturing partners.

What you will do

• Provide sponsor oversight of clinical CMOs and CTLs for manufacture and testing.
• Monitor quality performance metrics for CMOs, CTLs and critical suppliers.
• Maintain the Annual Product Quality Review process.
• Collaborate with MSAT and Technical Operations for Change Controls.
• Provide quality oversight and approval of process validation strategies and technology transfer.
• Support GMP inspection readiness and provide leadership during health authority inspections.
• Coordinate investigations, root cause analysis, and corrective and preventive actions.
• Serve as GMP quality for CMC regulatory submissions including IND, IMPD, and BLA/MAA modules.
• Facilitate quality risk management activities using ICH Q9 principles.
• Write, revise, review and/or approve SOPs and controlled documents.

Required qualifications

• Bachelor’s degree in chemistry, biochemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific disciplines.
• Minimum of 10 years’ experience in the pharmaceutical industry.
• 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 such as MasterControl or TrackWise.
• Strong proficiency in CMC regulatory submissions with direct experience reviewing IND/IMPD sections and 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.

Nice to have

• Higher degree (MS, PhD, PharmD)

Benefits

• bonus
• stock
• benefits

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. The company is headquartered in Miami, Florida.