Director, Analytical Quality Assurance

Gilead Sciences•Foster City, CA

About The Position

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.

Requirements

Demonstrated ability to evaluate analytical data, investigations, trends, and product quality risks to make sound, risk-based quality decisions.
Experience overseeing contract testing laboratories and external partners, including performance monitoring, issue resolution, and quality governance.
Excellent communication, collaboration, organization, and influencing skills, with the ability to effectively engage senior leadership and cross-functional stakeholders.
Strong critical thinking, problem-solving, and decision-making skills, with the ability to operate independently in complex and ambiguous environments.
Proven ability to lead, coach, and develop high-performing teams while fostering a culture of accountability, quality, and continuous improvement.
Experience in pharmaceutical quality, analytical sciences, Quality Control, Quality Assurance, or a related GMP-regulated environment, with progressive leadership responsibilities.
Bachelor's degree, MS or PhD in chemistry, microbiology, or related scientific field is preferred: 12+ years of relevant experience and a BS or BA
10+ years of relevant experience and a MS
8+ years of relevant experience and a PhD

Responsibilities

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.
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.
Provide quality oversight for contract QC testing laboratory activities, stability programs, analytical method validation, and transfers.
Review and approve analytical quality documents, including SOPs, specifications, methods, change controls, protocols, reports, investigations, deviations, CAPAs, and quality assessments.
Ensure analytical testing activities comply with applicable quality objectives, cGMP, GLP, ICH, FDA, EMA, and other regulatory requirements.
Oversee investigations related to OOS, OOT, atypical results, deviations, and laboratory incidents, ensuring timely, scientifically sound resolution and appropriate CAPA recommendations.
Provide quality oversight for contract partners and contract testing laboratories, including qualification, performance monitoring, audits, quality agreements, and resolution of documentation or compliance issues.
Maintain and continuously improve systems and processes for CAPA, change control, risk management, compliance, and analytical quality operations.
Manage audits and inspections related to analytical laboratories and testing activities, including regulatory inspections, customer audits, internal audits, and cGMP compliance audits.
Review and audit analytical data and CMC sections of NDA and global regulatory filings, as applicable.
Manage direct reports responsible for Analytical Quality Assurance.