Supplier Quality Engineer leading Preventive Quality projects and ensuring compliance with AS9145 standards at Boeing. Collaborating with suppliers and internal teams to optimize product deliverables.
About the role
- Associate Director of Quality Assurance Compliance managing inspection operations and regulatory compliance at Gilead. Collaborating with global teams to enhance inspection strategies and processes.
Responsibilities
- 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.
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.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans*
- paid time off
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