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 leading Analytical Quality Assurance within GMP-regulated environments, with a strong focus on quality governance, compliance, and team development. Proficient in managing contract testing laboratories and ensuring adherence to regulatory standards such as cGMP, GLP, and ICH.

Highest-signal resume keywords

Analytical Quality Assurance LeadershipRegulatory Compliance ManagementContract 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 ValidationQuality ControlQuality AssuranceRisk ManagementChange ControlCAPA ManagementInvestigational OversightSOP Review and ApprovalData AnalysisRegulatory Filing Review

Soft Skills

Excellent CommunicationCollaborationOrganizationInfluencing SkillsCritical ThinkingProblem-SolvingDecision-Making

Industry Keywords

CGMPGLPICHFDAEMAPharmaceutical QualityAnalytical SciencesQuality GovernanceQuality CulturePerformance Monitoring

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
Provide quality oversight for contract QC testing laboratory activities, stability programs, analytical method validation, and transfers
Review and approve SOPs, specifications, methods, change controls, protocols, reports, investigations, deviations, CAPAs, and quality assessments
Oversee investigations involving OOS, OOT, atypical results, deviations, and laboratory incidents
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 and processes
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

Progressive leadership experience in pharmaceutical quality, analytical sciences, Quality Control, Quality Assurance, or a related GMP-regulated environment
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, 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