Director, Product Quality Small Molecule
About The Position
At Gilead, the Director, Product Quality Small Molecule provides quality leadership across cross-functional teams in a matrix environment. The role drives alignment and decision-making through scientifically sound, risk-based evaluation of process and product quality data and development of patient-oriented strategies. It leads product quality strategy across the product lifecycle and supports product development, technology transfers, global regulatory filings, analytical methods, stability, specifications, and in-process controls. The Director leads Product Quality Team activities and uses the product quality risk register to identify, assess, and mitigate risks. The role monitors cross-functional data and trends, develops control strategies, authors and approves regulatory filings, supports health authority responses, assesses the quality impact of changes and events, and supports technology transfer and product launches. It also contributes to inspection readiness and applies science- and risk-based judgment to complex issues, communicating technical information to leadership, teams, and regulatory agencies. The role may act as delegate to the Senior Director, Product Quality Heads, as needed.
Responsibilities
- Provide quality leadership on cross-functional teams, driving alignment, decision-making, and risk-based evaluation of process and product quality data.
- Execute and drive product strategies involving product development, technology transfers, global regulatory filing strategies, analytical methods, stability, drug substance and drug product specifications, and in-process controls.
- Lead Product Quality Team activities to align product quality strategy, priorities, and deliverables across the product lifecycle.
- Use the product quality risk register to identify, assess, and mitigate product quality risks.
- Monitor and review cross-functional process and product data to identify trends and ensure quality and compliance risks are addressed and escalated as needed.
- Lead development of control strategies, including in-process controls, starting material, drug substance and drug product specifications, stability strategy, and comparability approaches.
- Author and approve product-quality regulatory filings and support responses to health authority questions.
- Provide cross-functional guidance to align product quality strategy across development, manufacturing, analytical, and regulatory stakeholders.
- Assess product quality impacts for changes, deviations, and events, and ensure appropriate implementation plans are developed.
- Support drug substance and drug product technology transfer and new product launches.
- Ensure inspection readiness, including PAI/PLI preparation, by participating as a product expert.
- Apply science- and risk-based evaluation to complex issues and 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.
Benefits
- Discretionary annual bonus eligibility
- Discretionary stock-based long-term incentives (eligibility may vary by role)
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
