Senior Director Quality Assurance Head, Small Molecules

3 weeks ago

San Francisco CA, United States Gilead Sciences Full time

Senior Director Quality Assurance Head, Small Molecules
Join Gilead Sciences to lead our independent Quality Assurance organization, responsible for a riskbased Pharmaceutical Quality System (PQS), final batch disposition, inspection performance, and a culture of continuous improvement and data integrity.
The Senior Director, Quality Assurance partners with Site and global Quality leaders to assure supply, quality, and compliance. The role drives strategic quality initiatives and provides independent oversight of manufacturing and testing activities.
Quality Leadership & Strategy
Own the site PQS aligned to our Quality Manual, overseeing policy, CAPA/change control, data integrity, risk-based approaches and periodic management reviews.
Run an independent QA function with authority for final batch disposition and QA oversight of manufacturing/testing, ensuring independence from production.
Lead the execution of QA responsibilities: complaints handling, investigations, escalation of serious GMP issues, internal audits/selfinspection, and training effectiveness.
Lead batch release decisioning, integrating crossfunctional inputs, and leverage digital tools and analytics as per our Quality digital roadmaps.
Compliance & Regulatory Affairs
Oversee QA and Compliance functions, ensuring timely release of products and batches.
Identify and manage quality risks across the product lifecycle and implement mitigation strategies.
Act as escalation point for complex/highimpact quality issues and decisions.
Lead, mentor and develop a highperforming quality team.
Collaborate closely with QC to maintain clear QA vs. QC accountability and technical rigor.
Represent Quality Assurance in site leadership forums and strategic initiatives.
PhD/ PharmD with 12+ years of experience.
12+ years experience in Biopharmaceutical or Pharmaceutical manufacturing quality assurance and quality control.
~Critical-thinking, creative problemsolving, independent resource determination.
~ Strong organizational and planning skills.
~ Expertise in industry best practices and trends across QA subfunctions.
~ In-depth understanding of business objectives and translation into quality priorities.
~ Capability to develop and improve complex concepts, techniques, standards and new applications.
~ Knowledge of medical devices and combination products is a plus.
~ Vision for QA functions and capability to shape the functions capabilities.
~ Inclusion (Encouraging Diversity)
Accountability (Taking Personal Responsibility)
This position may also be eligible for discretionary annual bonus, discretionary stockbased longterm incentives, paid time off, and a benefits package including companysponsored medical, dental, vision, and life insurance plans.
Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information, gender identity, veteran status or any other protected characteristic as required by applicable federal, state and local laws.

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