Sr Manager, Quality Assurance

Gilead Sciences • La Verne, CA

23h

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Manager, Quality Assurance at Gilead you will provide Quality Assurance leadership and oversight for Gilead’s Global Logistics operations supporting both clinical trial supply and commercial product distribution, with a primary focus on US market drug product supply. This role is responsible for deviation and CAPA oversight, change management support, quality oversight of third‑party logistics (3PL) service providers, and resolution of all DSCSA‑related events, ensuring full compliance with DSCSA, FDA, and applicable GDP regulations. The role partners closely with Global Logistics, Trade Operations, Supply Planning, and external service providers to ensure compliant, reliable distribution of Gilead products to patients. The successful candidate will join the Global Product Distribution & Affiliates QA team and be based in La Verne, CA

Requirements

• Bachelors degree and 8+ years of relevant experience OR Masters degree and 6+ years of relevant experience OR PhD and 2+ years of relevant experience
• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Responsibilities

• Quality Systems Oversight Support and/or approve deviations, investigations, and CAPAs associated with Global Logistics clinical and commercial operations, ensuring timely, thorough, and compliant resolution.
• Provide QA oversight and support for change management activities, including changes to distribution processes, transportation lanes, systems, and 3PL operations.
• Review and assess logistics‑related quality records, including shipping documentation, temperature excursions, and environmental monitoring data.
• Provide Quality Assurance oversight of primary US market drug product supply 3PL service providers, ensuring adherence to GDP, DSCSA, and Gilead quality standards.
• Monitor quality performance, trends, and metrics across logistics operations and partner with stakeholders to drive continuous improvement.
• Support vendor qualification, ongoing oversight, and issue resolution related to logistics service providers.
• Serve as QA lead supporting resolution of DSCSA‑related events, including suspect, illegitimate, and notification events, ensuring compliance with all relevant DSCSA and FDA requirements.
• Partner with Trade Operations, Global Logistics, and external partners to support DSCSA compliance across US distribution activities.
• Support and participate in FDA, NABP, and other regulatory inspections, audits, and internal audit programs related to distribution and logistics.
• Contribute to the development, review, and maintenance of SOPs and quality documentation supporting Global Logistics operations.
• Support development and delivery of training programs related to GDP, DSCSA, and logistics quality requirements.
• Participate in or lead cross‑functional projects and continuous improvement initiatives within GPD&A and Global Logistics.

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.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level