Director, Product Quality Leader, Biologics
Gilead
Gilead Sciences seeks a Director of Product Quality Leadership for biologics to provide strategic quality oversight on cross-functional teams, drive risk-based product strategies, and lead product quality activities across the development and commercial lifecycle.
Responsibilities
- Lead product quality team alignment on strategy, priorities, and deliverables across product lifecycle
- Drive identification and mitigation of product quality risks using science- and risk-based approaches
- Develop and oversee control strategies including specifications, in-process controls, and stability plans
- Review and approve regulatory filings; support responses to health authority questions and inspections
- Monitor process and product data trends to identify quality and compliance risks requiring escalation
Requirements
- 12+ years relevant experience with bachelor's degree in science, or 10+ years with advanced degree (MS, PharmD, PhD)
- Prior quality leadership and technical management experience in development or commercial programs
- Deep knowledge of cGMP principles, ICH guidelines, and regulatory frameworks (EP, JP, USP, 21 CFR)
- Direct experience with regulatory submissions (IND, NDA, BLA, MAA) and health authority inspections
- Demonstrated expertise in control strategy, comparability, drug substance/product development, and process validation
- Proven ability to lead cross-functional teams in matrix environments and influence decisions without direct authority
- Strong analytical skills to interpret complex data and develop science-based risk mitigation strategies
Vacancy posted 1 day ago
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