Full Job Description
· Provide quality leadership on cross-functional teams in a matrix environment, driving alignment and decision making, performing a scientifically sound and risk-based evaluation of process and product quality data, and developing patient-oriented strategies
• Execute/drive product strategies through in-depth quality and scientific knowledge related to product development, technology transfers, global regulatory filing strategies, analytical methods, stability, drug substance and drug product specifications and In-Process Controls (IPCs)
• Lead Product Quality Team (PQT) activities to align product quality strategy, priorities, and deliverables across the product lifecycle.
• Through the product quality risk register, drive identification, assessment, and mitigation of product quality risks using a science- and risk-based approach.
• Monitor and review cross-functional process and product data to identify trends and ensure quality and compliance risks are proactively addressed and escalated, as needed.
• Lead the development of control strategies, including in-process controls, starting material, drug substance and drug product specifications, stability strategy, and comparability approaches.
• Author and approve regulatory filings associated with product quality 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 impact 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 through participation as a product expert.
• Apply science- and risk-based evaluation to complex issues and develop practical, patient-focused solutions that balance quality, regulatory expectations, and business needs.
• Communicate complex quality and technical information clearly to leadership, cross-functional teams, and regulatory agencies.
• Act as delegate to the Senior Director, Product Quality Heads, as needed
The salary range for this position is: $191,250.00 - $247,500.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
