Senior Manager, Quality Control

THE OPPORTUNITY

The Senior Manager, Technical Operations Quality Control, is responsible for executing and operationalizing QC strategy across assigned programs and external testing partners (e.g., CDMOs/CTLs) from Phase 1 through commercialization. This role ensures the timely and compliant delivery of QC activities, including release and stability testing, method lifecycle management, and vendor oversight. 

The Senior Manager partners cross-functionally with Quality, Technical Operations, Regulatory, and Analytical Development to deliver program milestones, maintain inspection readiness, and support global regulatory submissions. This individual contributes to the development of QC strategy and drives continuous improvement in QC processes, systems, and external network performance. 

This role is located in our San Francisco headquarters with an expectation of 3 days per week in office.

WHAT YOU'LL DO

• Execute and operationalize QC strategy for assigned programs and external testing networks in alignment with QC and Quality organization strategy.  
• Lead QC activities across the product lifecycle (Phase 1 through commercial) for designated programs, ensuring effective implementation of phase-appropriate control strategies.  
• Support development and refinement of QC strategies, including methods, specifications, and testing approaches, in collaboration with Analytical Development and QC leadership.  
• Drive consistent execution and harmonization of QC methods, specifications, and practices across programs and external partners.  
•  Identify, assess, and escalate risks to QC performance, supply continuity, and compliance, and implement mitigation plans with cross-functional stakeholders. 
• Represent QC on program teams and sub-teams, ensuring alignment of analytical deliverables, timelines, and QC readiness for key CMC milestones. 
• Manage day-to-day execution of QC operations to ensure timely, compliant testing for clinical and commercial programs.  
• Coordinate and oversee release and stability testing (including CDMOs/CTLs), including review of analytical data, batch records, and supporting documentation; support CoA generation.  
• Lead execution of QC GMP processes (deviations, OOS/OOT, change controls, investigations) in collaboration with QA.  
• Coordinate QC documentation and logistics at external labs, including sampling plans, shipments, and reagent/inventory management.  
• Manage vendor performance and execution, including CTL/CDMO oversight and routine operational interactions.  
• Execute method lifecycle activities (qualification, transfer, validation, implementation, and monitoring) across internal and external labs.  

WHO YOU ARE AND WHAT YOU BRING

• BA/BS with 10 + years experience, MA/MS/MBA with 8+ years experience in Biochemistry, Chemistry, Biology, Virology, Chemical Engineering or a related discipline is preferred
• Technical expertise in a wide range of analytical methods for release and stability testing of monoclonal antibodies
• Strong scientific background in Quality Control and/or assay development in biotech industry with strong knowledge of cGMP/ICH/FDA/EMA regulations
• Expertise with analytical test method optimization, validation, and transfer as well as working with contract organizations