Director, Analytical Quality Assurance

Gilead Sciences

. Lead analytical quality oversight for external QC testing laboratories, stability programs, analytical methods, and related GMP analytical operations .

Posted 10/15/2026full-timeFoster City • California • United StatesLead💰 $210,375 - $272,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in pharmaceutical quality and analytical sciences, with a strong focus on Quality Control and Quality Assurance in GMP-regulated environments. Proven ability to lead teams, manage compliance, and oversee analytical quality systems while fostering a culture of collaboration and accountability.

Highest-signal resume keywords

Analytical Quality Assurance LeadershipGMP Regulatory ComplianceContract Testing Laboratory OversightAnalytical Data EvaluationTeam Development and Coaching

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical Method ReviewQuality Document ApprovalCAPA ManagementChange ControlRisk ManagementQuality AssessmentOOS InvestigationLaboratory AuditsRegulatory Filing ReviewAnalytical Quality Systems

Soft Skills

Excellent CommunicationCollaborationOrganizationInfluencing SkillsCritical ThinkingProblem-SolvingDecision-Making

Industry Keywords

CGMPGLPICHFDAEMAQuality GovernanceAnalytical SciencesPharmaceutical QualityQuality ControlQuality Assurance

About the role

Key responsibilities & impact

Lead analytical quality oversight for external QC testing laboratories, stability programs, analytical methods, and related GMP analytical operations
Provide quality governance for contract partners and testing laboratories
Partner cross-functionally with Manufacturing and external partners on product lifecycle and regulatory priorities
Lead the Analytical Quality Assurance team and foster accountability, collaboration, and a strong quality culture
Review and approve analytical quality documents, including SOPs, specifications, methods, change controls, protocols, reports, investigations, deviations, CAPAs, and quality assessments
Oversee OOS, OOT, atypical result, deviation, and laboratory incident investigations
Oversee contract partner and testing laboratory qualification, performance monitoring, audits, quality agreements, and compliance issue resolution
Improve CAPA, change control, risk management, compliance, and analytical quality systems
Manage analytical laboratory audits and regulatory, customer, internal, and cGMP compliance inspections
Review and audit analytical data and CMC sections of NDA and global regulatory filings
Manage direct reports responsible for Analytical Quality Assurance
Create inclusion, develop talent, and empower teams

Requirements

What you’ll need

Experience in pharmaceutical quality, analytical sciences, Quality Control, Quality Assurance, or a related GMP-regulated environment
Progressive leadership responsibilities
12+ years of relevant experience and a BS or BA, or 10+ years of relevant experience and an MS, or 8+ years of relevant experience and a PhD
Ability to evaluate analytical data, investigations, trends, and product quality risks
Experience overseeing contract testing laboratories and external partners
Excellent communication, collaboration, organization, and influencing skills
Strong critical thinking, problem-solving, and decision-making skills
Ability to lead, coach, and develop high-performing teams
Knowledge of cGMP, GLP, ICH, FDA, EMA, and other regulatory requirements

Benefits

Comp & perks

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical insurance
Company-sponsored dental insurance
Company-sponsored vision insurance
Company-sponsored life insurance