Director, Analytical Quality Assurance

Role: Lead analytical quality oversight within Gilead's biopharmaceutical operations, focusing on external QC testing labs, stability programs, and analytical methods to ensure compliance with GMP, GLP, ICH, FDA, EMA standards. Responsibilities include reviewing and approving analytical documents, overseeing investigations of quality issues, managing qualification and audits of contract labs, and driving continuous improvement in quality systems. Requirements: 8+ years in pharmaceutical quality, analytical sciences, or GMP-regulated environments; advanced degrees (MS or PhD) preferred. Skills include expertise in analytical data evaluation, regulatory compliance, laboratory oversight, and cross-functional collaboration. High-Value: focus on analytical quality assurance for biopharma products, regulatory audits, cGMP compliance, and managing external partnerships. WorkSetup: on-site with leadership responsibilities; no travel specified.