onsite
Senior Manager, Quality Assurance - Gilead Sciences
Software Engineer
Senior Quality Assurance leader responsible for overseeing GMP compliance, validation activities, and risk‑based quality systems in a pharmaceutical environment, driving continuous improvement and cross‑functional collaboration.
About the role
Key Responsibilities
- Lead the QA organization to ensure compliance with GMP, FDA, and other regulatory requirements across all manufacturing sites.
- Develop, execute, and oversee validation master plans for equipment, processes, and computer systems.
- Implement risk‑based quality strategies, including CAPA management and root‑cause investigations.
- Drive continuous improvement initiatives using Lean, Six Sigma, and quality metrics to enhance product quality and operational efficiency.
- Partner with cross‑functional teams (R&D, Manufacturing, Supply Chain) to embed quality standards throughout product lifecycle.
Requirements
- 10+ years of QA experience in the pharmaceutical or biotech industry, with at least 5 years in a managerial or senior leadership role.
- Deep knowledge of GMP, FDA regulations, and validation methodologies (IQ/OQ/PQ).
- Proven track record of leading risk‑based quality programs and successful CAPA implementation.
- Strong analytical and problem‑solving skills, with experience applying Lean or Six Sigma tools.
- Excellent communication and people‑management abilities to influence and develop high‑performing teams.