Senior Manager, Quality Assurance
Core
Strategizing and delivering Quality Assurance objectives for the Foster City Manufacturing New Chess Facility, supporting startup, operational readiness, and steady-state manufacturing and analytical operations.
Role type
Senior Manager, Quality Assurance (Site-based Individual Contributor)
Builds
Biologics drug products and analytical methods in compliance with GMP
Domain
Biopharmaceutical Manufacturing / Quality Assurance
Required skills
GMP/GLPs, Quality Risk Management, CAPA, Regulatory Compliance (FDA/Health Canada), Manufacturing Operations, Analytical Methods, Cross-functional Collaboration, Documentation Control, Audit Management, Training & Mentoring
Preferred skills
Six Sigma/DMAIC, Risk Management Tools (HACCP/FMEA), ASQ Certification, Computer System Validation (CSV)
Technologies
Electronic Records and Signature Systems, Manufacturing Execution Systems (implied by GMP context)
Responsibilities
Oversee external QC laboratories and method lifecycle activities; Review and approve laboratory investigations (OOS/OOT/deviations); Manage QA personnel and performance reviews; Approve GMP documentation and specifications; Participate in internal GMP audits and regulatory inspections; Lead or support CAPA recommendations and compliance audits; Interface with contract manufacturers and regulatory agencies.
Seniority
Senior Manager, hands-on IC with leadership responsibilities
