About Gilead Sciences

Gilead Sciences is a biopharmaceutical leader with over 35 years of innovation, tackling global health challenges like HIV, viral hepatitis, COVID-19, oncology, and inflammatory diseases. Headquartered in Foster City, California, Gilead develops life-changing therapies that improve access to treatment worldwide. Our mission drives relentless collaboration and determination, making every team member vital to scientific breakthroughs. As a Senior Director in Quality Assurance, you'll join a culture prioritizing inclusion, development, and empowerment.

Role Overview

The Senior Director — Quality Assurance Head, Small Molecules, leads the independent QA organization at our Foster City site. This role ensures a risk-based Pharmaceutical Quality System (PQS), final batch disposition, inspection excellence, and a culture of data integrity and continuous improvement. Partnering with site and global Quality leaders, you'll secure supply chain compliance while fostering innovation in small molecule manufacturing.

Focus on Leadership and Strategy

Demonstrate ownership of site PQS aligned to Gilead's Quality Manual, governing policies, CAPA, change control, and risk-based decisions. Run an autonomous QA function with authority for batch release, independent from production, per GMP standards.

Key Responsibilities

Your impact will span multiple domains:

• Oversee QA and Compliance for timely product, material, and batch releases meeting quality standards.
• Champion initiatives to reduce deviations, shorten cycle times, enhance CAPA effectiveness, and boost audit readiness.
• Identify lifecycle quality risks, implement mitigations, and escalate high-impact issues.
• Lead, mentor, and develop a high-performing QA team promoting accountability and transparency.
• Represent QA in site leadership, integrating cross-inputs for batch decisions using digital analytics.

Compliance and Regulatory Expertise

Ensure site-wide adherence to cGMP, FDA, EMA, ICH, and global regulations. Represent Gilead confidently to health authorities, navigating complex audits with poise.

Qualifications & Requirements

Basic Qualifications:

• PhD/PharmD with 12+ years, MS with 12+ years, or BS with 14+ years relevant experience.

Preferred Qualifications:

• 12+ years in biopharmaceutical/pharmaceutical QA/QC, especially small molecules.
• 5+ years people leadership.
• Critical thinking, independence, organizational skills, and trend foresight.
• Excellent communication, influencing, and rapport-building across levels.
• Deep business acumen translating to quality priorities.

Benefits & Perks

Gilead offers premium compensation packages, including estimated $280,000-$380,000 base for this senior role, plus bonuses and equity. Enjoy comprehensive health benefits, 401(k) matching, generous PTO, wellness stipends, and family leave. Our Foster City campus features modern facilities, onsite fitness, and dining.

Career Growth

As a people leader, you'll evolve Gilead's culture, driving employee aspirations. Access leadership development, global rotations, and QA career paths emphasizing regulatory representation and digital transformation. Gilead invests in your growth to tackle HIV, oncology, and inflammatory disease challenges.

Why Join Gilead

Join a purpose-driven company creating a healthier world. In Foster City, collaborate on groundbreaking therapies amid Bay Area innovation. Experience impactful work, bold ambitions, and a supportive environment where QA leaders shape compliance and supply for millions. Gilead's focus on HIV treatments like Biktarvy, oncology advances, and inflammation solutions positions you at the forefront of biopharma.

Role FAQs

Q: What experience is required?
A: 12-14+ years in QA/QC, with leadership in biopharma manufacturing.

Q: Is travel involved?
A: Occasional for audits and global meetings.

Q: What's the team structure?
A: Lead a high-performing QA team, partnering distinctly with QC.

Q: How does Gilead support work-life balance?
A: Flexible hours, PTO, and wellness programs prioritize employee well-being.

Q: What's unique about small molecules at Gilead?
A: Aligns with our antiviral and oncology pipelines, ensuring compliant, innovative supply.