Director, Product Quality – Small Molecule

Gilead Sciences

. Provide quality leadership on cross-functional teams in a matrix environment .

Posted 11/3/2026full-timeSanta Monica • California • United StatesLead💰 $191,250 - $247,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in product quality leadership, regulatory filing strategies, and risk-based evaluations while developing patient-oriented solutions. Proficient in cross-functional collaboration and communication of complex quality information to stakeholders.

Highest-signal resume keywords

Product Quality LeadershipRegulatory Filing StrategiesRisk-Based EvaluationsTechnology TransfersAnalytical Methods

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality KnowledgeScientific KnowledgeControl StrategiesIn-Process ControlsStability StrategiesComparability ApproachesRegulatory FilingsProduct Quality Impact AssessmentInspection ReadinessPatient-Oriented Strategies

Soft Skills

Cross-Functional GuidanceCommunication SkillsDecision MakingLeadership

Industry Keywords

Product DevelopmentQuality DataCompliance RisksHealth Authority QuestionsDrug SubstanceDrug ProductQuality Risk RegisterNew Product Launches

About the role

Key responsibilities & impact

Provide quality leadership on cross-functional teams in a matrix environment
Drive alignment and decision making
Perform scientifically sound and risk-based evaluations of process and product quality data
Develop patient-oriented strategies
Execute and drive product strategies through product development, technology transfers, global regulatory filing strategies, analytical methods, stability, specifications, and IPCs
Lead Product Quality Team activities across the product lifecycle
Drive identification, assessment, and mitigation of product quality risks through the product quality risk register
Monitor and review cross-functional process and product data to identify trends and proactively address and escalate quality and compliance risks
Lead development of control strategies, stability strategies, and comparability approaches
Author and approve product-quality regulatory filings and support responses to health authority questions
Provide cross-functional guidance across development, manufacturing, analytical, and regulatory stakeholders
Assess product quality impact for changes, deviations, and events and ensure implementation plans are developed
Support technology transfer and new product launches
Ensure inspection readiness, including PAI/PLI preparation, through participation as a product expert
Develop practical, patient-focused solutions balancing quality, regulatory expectations, and business needs
Communicate complex quality and technical information to leadership, cross-functional teams, and regulatory agencies
Act as delegate to the Senior Director, Product Quality Heads, as needed

Requirements

What you’ll need

In-depth quality and scientific knowledge related to product development
Knowledge of technology transfers
Knowledge of global regulatory filing strategies
Knowledge of analytical methods
Knowledge of stability, drug substance and drug product specifications, and In-Process Controls (IPCs)
Ability to perform scientifically sound, science-based, and risk-based evaluations of process and product quality data
Ability to develop patient-oriented strategies
Ability to develop control strategies, including in-process controls, starting material, drug substance and drug product specifications, stability strategy, and comparability approaches
Ability to author and approve regulatory filings associated with product quality
Ability to assess product quality impact for changes, deviations, and events
Ability to support drug substance and drug product technology transfer and new product launches
Ability to ensure inspection readiness and participate as a product expert
Ability to communicate complex quality and technical information clearly to leadership, cross-functional teams, and regulatory agencies

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