About Gilead Sciences

Gilead Sciences is a biopharmaceutical leader dedicated to creating a healthier world through innovative therapies. For over 35 years, Gilead has pioneered treatments for HIV/AIDS, viral hepatitis, COVID-19, oncology, and inflammatory diseases. Headquartered in Foster City, California, the company drives scientific breakthroughs that improve lives globally, from life-saving antivirals to cutting-edge cancer immunotherapies. Gilead's commitment to collaboration, determination, and access ensures therapies reach those in need. Joining Gilead means contributing to bold ambitions in life-changing medicine.

Role Overview

The Senior Director, Quality Assurance - Biologics, based in Foster City, California, leads the site's independent QA organization. This pivotal role ensures an effective, risk-based Pharmaceutical Quality System (PQS), final batch disposition, inspection readiness, and a culture of data integrity and continuous improvement. Reporting to site and global Quality leaders, you will partner to secure supply chain compliance while championing Gilead's mission in biologics for HIV, oncology, and inflammatory diseases. Ideal for seasoned leaders ready to drive quality excellence in biopharma.

Key Focus Areas

Emphasize hands-on leadership in QA oversight of manufacturing, complaints, investigations, audits, and training. Leverage digital tools for batch release and analytics to enhance decision-making.

Key Responsibilities

As Senior Director, you will:

• Demonstrate ownership of the site PQS, including policy oversight, CAPA/change control, data integrity, and risk-based management reviews.
• Run an independent QA function with authority for final batch disposition and GMP independence from production.
• Ensure site-wide cGMP compliance with FDA, EMA, ICH regulations; represent Gilead in health authority inspections.
• Oversee timely product, material, and batch releases; champion improvements to reduce deviations and cycle times.
• Lead, mentor, and develop a high-performing QA team, fostering accountability and transparency.
• Collaborate with QC, manufacturing, and site leadership; act as escalation point for complex quality issues.

Qualifications & Requirements

Basic Qualifications:

• Doctorate + 12 years, Master’s + 12 years, Bachelor’s + 14 years, Associate + 16 years, or High School Diploma/GED + 18 years in biopharmaceutical or pharmaceutical quality control.

Preferred Qualifications:

• 10+ years biopharma quality experience; 5+ years senior leadership.
• Extensive knowledge of QA sub-functions, industry best practices, and trends.
• Critical thinking, organizational skills, excellent verbal/written communication, and interpersonal abilities.
• Proven ability to establish credibility, navigate audits, and leverage digital tools.

Benefits & Perks

Gilead offers a premium compensation package tailored for top talent:

• Competitive base salary estimated at $280,000 - $380,000 annually, plus bonuses and equity.
• Comprehensive health benefits including medical, dental, vision, and wellness programs.
• Generous 401(k) matching, retirement savings, and financial planning support.
• Paid time off, family leave, and flexible work options.
• State-of-the-art facilities in Foster City with onsite amenities.

Career Growth

Gilead invests in people leaders as the cornerstone of employee experience. This role positions you for executive impact, with opportunities in global Quality, site leadership, or strategic initiatives. Access leadership development, mentoring, and cross-functional projects advancing biologics in HIV, oncology, and inflammation. Grow in a culture empowering inclusion, development, and aspiration fulfillment.

Why Join Gilead

Join a team relentlessly tackling health challenges. At Gilead, your expertise in biologics QA directly supports therapies transforming lives—from HIV management to oncology breakthroughs and inflammatory disease solutions. Foster City offers an innovative hub with collaborative energy, proximity to Silicon Valley, and a vibrant Bay Area lifestyle. Be part of creating possible, together, with a company valuing every employee's role in scientific innovation.

Role FAQs

Q: What experience is required?
A: Minimum 12-18 years in biopharma quality based on education, with senior leadership preferred.

Q: Is travel required?
A: Occasional travel for global Quality alignment and inspections.

Q: What makes this role unique?
A: Independent authority for batch disposition in biologics, driving digital QA transformation at a top biopharma.

Q: How does Gilead support career development?
A: Through people leadership programs, training, and strategic forums emphasizing inclusion and growth.

Q: What's the location like?
A: Foster City, California—scenic, innovative, with easy Bay Area access.