Senior Manager, Quality Control

Role: Senior Manager, Technical Operations Quality Control, responsible for executing and operationalizing the QC strategy across early to commercial phases for biopharmaceutical programs, including monoclonal antibodies. Responsibilities: oversee QC activities such as release and stability testing, method lifecycle management, and vendor oversight of external laboratories; support development and refinement of QC strategies; ensure compliance with cGMP/ICH/FDA regulations; manage risk mitigation, program readiness, and external partner performance; coordinate QC documentation, sampling, and testing logistics. Qualifications: BA/BS with 10+ years or MA/MS with 8+ years in Biochemistry, Chemistry, Biology, or related; strong expertise in analytical methods for biologics, validation, transfer, and cGMP compliance. HighValue: biologics (monoclonal antibodies), QC strategy development, external testing oversight, clinical to commercial lifecycle, regulatory compliance. WorkSetup: based in San Francisco, hybrid (3 days onsite).