Senior Manager, GMP QA (Biologics) – Tech Transfer

Regulatory Jobs; Palo Alto (CA); On-site; USD 158,000 - 185,000; Full time

Job summary

Summit Therapeutics Inc. is seeking a Senior Manager of Technical QA (GMP) to provide comprehensive quality oversight across the oncology product lifecycle.

You will lead process validation, technology transfer, comparability, and lifecycle changes while interfacing with MSAT and manufacturing partners to ensure global GMP compliance. The role requires a seasoned quality leader with deep biologics GMP knowledge, strong risk management skills, and experience supporting IND/IMPD/BLA/MAA regulatory

Qualifications

• Bachelor’s degree in chemistry, biochemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific disciplines.
• 10+ years in pharma with 5+ years in commercial drug substance and drug product manufacturing.
• Biologics experience essential; working knowledge of analytical lab testing.
• Experience using e-QMS to implement quality systems (MasterControl, TrackWise).
• Demonstrated ability to manage CMOs.
• Expertise in manufacturing/analytical/validation/change-control for biologics.
• Experience designing and implementing quality systems and risk tools.
• Experience supporting US and international health authority inspections.
• Strong knowledge of FDA/EMA/MHRA/ICH/PIC/S GMP for biologics.
• Knowledge of process/ Cleaning validation and equipment qualification in biologics.
• Excellent communication, both oral and written.
• Ability to work independently on multiple programs in a fast-paced environment.
• Attention to detail and strong work ethic.
• Excellent interpersonal and collaborative skills.

Responsibilities

• Provide sponsor oversight of clinical CMOs and CTLs for manufacturing and testing.
• Oversee CTLs for clinical and commercial testing, methods, transfers, validations, stability, specs.
• Monitor quality performance metrics with CMOs/CTLs and drive risk mitigation and improvements.
• Maintain Annual Product Quality Review with trend analysis and management reporting.
• Collaborate on change controls for development, tech transfer, scale-up, and verification; lead weekly Change Control meetings.
• Oversee process validation strategies, continued process verification, comparability protocols, and lifecycle validation.
• Oversee technology transfer between development, clinical and manufacturing facilities.
• Support inspection readiness and lead health authority inspections and supplier audits.
• Coordinate investigations, root cause analysis, risk assessments, and CAPA.

Job description

Summit Therapeutics Inc. is seeking a Senior Manager of Technical QA (GMP) to provide comprehensive quality oversight across the oncology product lifecycle.

You will lead process validation, technology transfer, comparability, and lifecycle changes while interfacing with MSAT and manufacturing partners to ensure global GMP compliance. The role requires a seasoned quality leader with deep biologics GMP knowledge, strong risk management skills, and experience supporting IND/IMPD/BLA/MAA regulatory