On-Site 4 days per week at our Palo Alto, CA or Princeton, NJ office

Overview of Role:

The Senior Manager of Technical QA (GMP) reports to the Senior Director of Technical QA (GMP) and provides comprehensive GMP quality oversight across the product lifecycle for Summit's oncology portfolio. This role supports process validation, continued process verification, technology transfer, comparability assessments, product lifecycle management, and post-approval changes. The Senior Manager serves as the primary quality interface between internal MSAT and Technical Operations teams and external manufacturing partners, ensuring compliance with global GMP requirements while driving continuous improvement and effective change management. The position requires a seasoned quality manager capable of operating at both strategic and tactical levels, with a track record of driving GMP compliance in the development of biologics.

Role and Responsibilities:

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

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

This is the pay for this position

Pay Transparency

$158,000-$185,000 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

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