Gilead Sciences · 2 months ago
Senior Director — Quality Assurance Head, Small Molecules
United States - California - Foster City
Full-time
Hybrid
Director/Executive
$243K/yr - $315K/yr
12+ years expGilead Sciences is dedicated to creating a healthier world by developing therapies for serious diseases. They are seeking a Senior Director of Quality Assurance to lead the site’s independent Quality Assurance organization, ensuring compliance with regulations and improving quality systems. The role involves overseeing QA functions, leading a team, and fostering a culture of continuous improvement.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Demonstrate ownership of a site Pharmaceutical Quality System (PQS) aligned to our Quality Manual, including policy/standards oversight, CAPA/change control governance, data integrity, risk-based approaches and periodic management reviews
Able to run an independent QA function, with authority for final batch disposition, QA oversight of manufacturing/testing, and independence from production per our GMP Quality Manuals (Gilead/Kite)
Hands-on leadership ensuring QA responsibilities are executed: complaints handling, investigations, escalation of serious GMP issues, internal audits/self inspection, and training effectiveness
Demonstrated leadership of batch release decisioning (jurisdiction control, cross input integration), leveraging digital tools and analytics per our Quality digital roadmaps
Ensure site-wide compliance with cGMP, FDA, EMA, ICH, and other applicable regulations
Comfortable representing the company to health authorities; able to navigate challenging audit situations—capabilities explicitly called out in our QA career paths
Oversee Quality Assurance (QA) and Compliance functions
Ensure timely release of products, materials, and batches in accordance with quality standards
Champions continuous improvement to reduce deviations and cycle times, and to improve CAPA effectiveness and audit readiness
Identify and manage quality risks across the product lifecycle and implement mitigation strategies
Acts as an escalation point for complex/high impact quality issues and decisions
Lead, mentor, and develop a high-performing quality team
Foster a culture of accountability, transparency, and continuous improvement
Demonstrated leadership of batch release decisioning (jurisdiction control, cross input integration), leveraging digital tools and analytics per our Quality digital roadmaps
Builds high performing QA teams and partners closely with QC (clear QA vs. QC accountability split) to ensure technical rigor and compliance
Represent Quality Assurance in site leadership forums and strategic initiatives
Qualification
Required
PhD/ PharmD with 12+ years of experience
OR
MS with 12+ years of experience
OR
BS with 14+ years of experience
Demonstrate ownership of a site Pharmaceutical Quality System (PQS) aligned to our Quality Manual, including policy/standards oversight, CAPA/change control governance, data integrity, risk-based approaches and periodic management reviews
Able to run an independent QA function, with authority for final batch disposition, QA oversight of manufacturing/testing, and independence from production per our GMP Quality Manuals (Gilead/Kite)
Hands-on leadership ensuring QA responsibilities are executed: complaints handling, investigations, escalation of serious GMP issues, internal audits/self inspection, and training effectiveness
Demonstrated leadership of batch release decisioning (jurisdiction control, cross input integration), leveraging digital tools and analytics per our Quality digital roadmaps
Ensure site-wide compliance with cGMP, FDA, EMA, ICH, and other applicable regulations
Comfortable representing the company to health authorities; able to navigate challenging audit situations—capabilities explicitly called out in our QA career paths
Oversee Quality Assurance (QA) and Compliance functions
Ensure timely release of products, materials, and batches in accordance with quality standards
Champions continuous improvement to reduce deviations and cycle times, and to improve CAPA effectiveness and audit readiness
Identify and manage quality risks across the product lifecycle and implement mitigation strategies
Acts as an escalation point for complex/high impact quality issues and decisions
Lead, mentor, and develop a high-performing quality team
Foster a culture of accountability, transparency, and continuous improvement
Builds high performing QA teams and partners closely with QC (clear QA vs. QC accountability split) to ensure technical rigor and compliance
Represent Quality Assurance in site leadership forums and strategic initiatives
Preferred
12+ years' experience in Biopharmaceutical or Pharmaceutical manufacturing quality assurance and quality control. Stays ahead of shifting trends in industry
5+ years of people leadership experience
Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems
Strong organizational and planning skills
Shows excellent verbal and written communication skills and collaborative interpersonal skills. Experience over a broad set of Quality Assurance sub-functions with extensive knowledge of industry best practices and trends
Ability to quickly establish credibility with diverse audiences and be perceived as a leader
Excellent verbal, written, and interpersonal communication skills are required. Must possess excellent influencing skills
Significant in-depth understanding of business objectives and how they translate into quality priorities
Must have the experience and confidence necessary to work with senior executives, and the ability to build rapport with employees at all levels
Must be able to exercise judgment and independently determine and take appropriate action where precedents may not exist
In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally
Must be able to develop and improve complex concepts, techniques, standards and new applications based on quality principles and theories
Knowledge of medical devices and combination products is a plus
Demonstrated an ability to develop a vision for Quality Assurance functions and have shaped the capabilities of the function to fulfill that vision
Strong hiring and staff development skills, with the ability to motivate and engage individuals
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-09
Company data provided by crunchbase