Director, Quality

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
 

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses

worldwide. Gilead Sciences is currently seeking an Director level position to be a Product Quality Lead (PQL), Quality Assurance, in the Pharmaceutical Development and Manufacturing (PDM) organization. The PQL is a strategic matrixed leadership position responsible for end-to-end product quality strategy. The PQL will serve as an individual contributor and as the primary Quality representative on the PDM Product Strategy Team(s), and lead of the Product Quality Team. The candidate should have a scientific and technical understanding of drug development and commercialization and be able to provide effective quality oversight and feedback for their assigned program(s) by liaising between the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC, and the wider PDM Quality organization. The successful candidate must have experience in a biotechnology and pharmaceutical development environment and strong knowledge of cGMP quality systems. This is an on-site position based at our Foster City headquarters.

*Prior Quality leadership and technical management experience in development and/or commercial programs.*

Job Functions:

• Accountable for end-to-end quality compliance of the assigned product/program, which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log.

• Serve as the primary Quality representative in the PDM meeting.

• Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones.

• Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified, mitigated and, if necessary, escalated in a timely manner.

• Review and approve the strategy for change control(s) impacting the product/program lifecycle.

• Provide technical oversight of Major and/or Critical Deviations, CAPAs, Biological Product Deviation and Complaints.

• Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with regulatory communications as needed (e.g. responses to agency information requests, the Notified Body Option).

• Provide oversight for changes to drug substance and drug product CMC details.

• Accountable for PAI/PLI readiness and supports Gilead PAI/PLI inspection preparation efforts and post-PAI/PLI follow up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead Sites.

• Support drug substance and drug product technology transfer, and new product launches.

• Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products.

• Accountable for medical device/ combination product quality compliance: engage/liaise with medical device product engineering, development, and quality teams.

• Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes).

• Perform work that requires independent decision making and the exercise of independent judgment.

• Serve as the delegate for Pillar Lead, as needed, for meeting and decision making.

Knowledge, Experience and Skills:

• In-depth understanding and application of GMP principles, concepts, best practices, and standa