Senior Manager of Technical QA (GMP)

Summit Therapeutics•Palo Alto, CA

10d•Onsite

About The Position

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. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. On-Site 4 days per week at our Palo Alto, CA or Princeton, NJ office. 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.

Requirements

Bachelor’s degree in chemistry, biochemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific disciplines.
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.

Nice To Haves

Higher degree (MS, PhD, PharmD) preferred

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.