Manages the logistics to support regulatory inspections at GSI Foster City including notification process, inspection support team (IST), prep room and inspection rooms and post-inspection activities
Build inspection readiness tools, templates and training materials for perpetual readiness for GSI FC
Management of all inspection related documentation including document retention and tracking
Management of post-inspection activities including upload of inspection documents in GVault
Lead periodic inspection readiness activities for GSI FC including annual mock inspection, inspection logistics drill, inspection readiness meeting with different functional areas
Design and implement comprehensive inspection plans for all manufacturing sites, including raw materials, in-process materials, and finished products, aligned with regulatory requirements.

BS/BA degree in Biology, Sciences, or related discipline and a minimum of 10+ years of related experience; OR MS/MA degree in Biology, Sciences, or related discipline and a minimum of 8+ years of related experience; OR PhD in related discipline and a minimum of 5+ years of related experience
Knowledge and practical application of domestic and global regulations including 21 CFR Parts 4, 11, 203, 205, 210, 211, 600, 610, 820; EudraLex Volume 4 and applicable annexes; EU Good Distribution Practices for Medicinal Products, QMSR/ISO13485 and Health Canada GMP/GDP guidance; as well as ICH, ISO and USP / EP compendial standards
Experience in the biotech or pharmaceutical industry is required.
Excellent knowledge of computer systems; i.e. Microsoft Word, Excel, Powerpoint, MSTeams, and Veeva Vault
Working knowledge of AI, machine learning, and advanced analytics concepts as applied to Quality, Compliance, and Inspection Management.
Ability to translate complex data and AI‑enabled insights into clear, actionable, inspection‑ready narratives for Health Authorities and senior leadership.

Associate Director, Quality Assurance Compliance

Key skills