Assoc Director, Quality Assurance (Global Supplier Quality)

Gilead Sciences, Inc. • Foster City, CA

58d

About The Position

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description We are seeking a dynamic and experienced Associate Director to join the Global Supplier Quality team within External Quality Operations. This leadership role will provide strategic direction and operational oversight for biologics-related material categories (e.g., single-use systems, resins, filters, media, excipients). The Associate Director will serve as a key quality leader, driving supplier performance, risk mitigation, and lifecycle management across a global network. This role requires strong technical expertise, external relationship management, and the ability to influence cross-functional teams and senior stakeholders.

Requirements

• BA/BS degree and 10+ years of relevant experience; OR
• MA/MS degree and 8+ years of relevant experience; OR
• PhD/PharmD and 5+ years of relevant experience
• Degree in science or engineering with relevant GMP experience
• Demonstrated leadership in managing external suppliers in a regulated environment
• At least 4+ years of experience overseeing CDMOs or suppliers

Nice To Haves

• Deep understanding of biologics manufacturing and raw material categories (e.g., SUS, filtration, extractables/leachables)
• Experience with Quality Management Systems, regulatory inspections, and supplier audits
• Strong cross-functional collaboration skills with experience influencing at multiple organizational levels
• Strong understanding of incoming material inspection processes, including sampling strategies (e.g., AQLs), certification protocols, and their application in biologics manufacturing
• Proficiency in SAP or similar ERP systems
• Exposure to FDA inspections, mock audits, and quality systems assessments
• Background in process development, manufacturing, or technical development is a plus
• Proven ability to lead in a fast-paced, evolving environment with a strategic mindset

Responsibilities

• Provide strategic quality leadership for biologics material suppliers across internal and external manufacturing networks
• Lead supplier investigations, deviations, and CAPAs, ensuring timely resolution and systemic improvements
• Oversee supplier-initiated changes and global change notifications, including impact assessments and cross-functional implementation
• Drive supplier selection, onboarding, and lifecycle management in collaboration with Quality, Supply Chain, Technical Development, Manufacturing Operations
• Lead negotiation and governance of Quality Agreements with key suppliers and internal partners
• Monitor supplier performance, risk indicators, and compliance trends; present insights to senior leadership
• Ensure data integrity and alignment of supplier master data in SAP and related systems
• Oversee and ensure timely, high-quality responses to audit observations, collaborating with internal and external stakeholders to drive sustainable remediation and readiness
• Apply quality risk management principles across materials and supplier decisions
• Lead or support cross-functional initiatives to optimize raw material and supplier lifecycle management, with a focus on risk mitigation, compliance, and continuous improvement
• May manage and mentor team members depending on organizational needs

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees