Sr Manager, Quality Assurance

Role Summary

Senior Manager, Quality Assurance at Gilead provides Quality Assurance leadership and oversight for Global Logistics operations supporting both clinical trial supply and commercial product distribution, with a primary focus on US market drug product supply. The role oversees deviations, CAPAs, change management, and the quality oversight of third‑party logistics providers, including resolution of DSCSA‑related events to ensure compliance with DSCSA, FDA, and GDP regulations. The successful candidate will join the Global Product Distribution & Affiliates QA team and be based in La Verne, CA.

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.
• 3PL & Distribution Oversight
  • 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.
• DSCSA & Regulatory Compliance
  • 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.
• Procedures, Training & Continuous Improvement
  • 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.

Qualifications

• Bachelors degree and 8+ years of relevant experience
• Masters degree and 6+ years of relevant experience
• PhD and 2+ years of relevant experience

Skills

• People Leader Accountabilities
  • 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.

Education

• Bachelors degree with 8+ years of relevant experience
• Masters degree with 6+ years of relevant experience
• PhD with 2+ years of relevant experience