About this role
Job Description
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Key Responsibilities
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Lead analytical quality oversight for external QC testing laboratories, stability programs, analytical methods, and related GMP analytical operations, ensuring activities, investigations, documentation, and quality decisions are scientifically sound, risk-based, and compliant with applicable regulatory requirements.
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Provide quality governance for contract partners and testing laboratories, partner cross-functionally with Manufacturing, and external partners to support product lifecycle and regulatory priorities, and lead the Analytical Quality Assurance team while fostering accountability, collaboration, and a strong quality culture.
Job Responsibilities:
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Provide quality oversight for contract QC testing laboratory activities, stability programs, analytical method validation, and transfers.
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Review and approve analytical quality documents, including SOPs, specifications, methods, change controls, protocols, reports, investigations, deviations, CAPAs, and quality assessments.
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Ensure analytical testing activities comply with applicable quality objectives, cGMP, GLP, ICH, FDA, EMA, and other regulatory requirements.
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Oversee investigations related to OOS, OOT, atypical results, deviations