Director, Product Quality Lead (PQL), Small Molecule Global Quality (United States - California - Foster City)

This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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 Summary:

The Product Quality Lead (PQL) supports one or more assigned products/programs and serves as the   serve as a product expert provid ing   technical , scientific   and strategic   expertise and leadership to Product CMC (Chemistry Manufacturing and Controls) /  Product Development and Manufacturing  ( PDM )  Team   and   Product Quality   Team (PQT)  during clinical development through   commercializatio n, ,   acting as the single point of   contact for   product quality.   The PQL   will define the product Quality and Compliance strategy for the   assigned   product s   by   leveraging   their   understanding of product development to   facilitate the   execution of the strategies that enable the efficient commercialization of   products. The   PQL is responsible   for   end-to-end   Product Quality deliverables, including ownership, authoring, and review of GMP and regulatory document ation  (including Product Quality sections of filings such as JOS), and management of product quality data such as comparability assessments, Annual Product Quality Reviews (APQRs), and product quality risk assessments.   The PQL is   responsible   for   evaluating and driving overall Product   Health by   proa c tively   identifying   and mitigating product   risks   and   issues, ensuring continuous improvement   throughout   the product lifecycle . The role supports cross-functional   Product Quality initiatives to strengthen compliance,   enhance   product   quality,   and   enable   robust   lifecycle management.   The PQL also serves as the primary Quality interface for alliance management and due diligence activities, ensuring alignment and effective collaboration with external partners.  

Job Functions:  

• Provide quality leadership on cross-functional teams in a matrix environment, driving alignment and decision making, performing a scientifically sound and risk-based evaluation of process and product quality data, and developing patient-oriented strategies  

• Execute/drive product strategies through strong quality and scientific   knowledge   related to   product development,   technology transfers, global regulatory filing strategies, analytical method s , stability,   drug substance and drug   product specifications   and In-Process Controls (IPCs) 

• Lead Product Quality Team (PQT) activities to   align on   product   quality strategy, priorities, and deliverables across the product lifecycle.  

• Through the product quality risk register , d rive identification, assessment, and mitigation of product quality risks using a science- and risk-based approach.  

• Monitor and review cross-functional process and product data to   identify   trends and ensure quality and compliance risks are proactively addressed and escalated, as needed.  

• lead the   d evelop ment   of   control   strategies, including   in-process   control,   starting   material, drug substance and drug product   specifications, stability strategy, and comparability approaches.  

• R eview and   approve   regulatory   filings and support responses to health authority questions.  

• Provide   cross-functional guidance to align   product   quality strategy across   d evelopment,   m anufacturing,   a nalytical, and   r egulatory stakeholders.  

• Assess product quality impact for changes, deviations, and events, and ensure   appropriate   implementation   plans are   developed .  

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

• Ensure inspection readiness, including PAI/PLI preparation   through   participation as a   product   expert   

• Apply science- and risk-based evaluation to complex issues and develop practical, patient-focused solutions that balance quality, regulatory expectations, and business needs.  

• Communicate complex quality and technical information clearly to leadership, cross-functional teams, and regulatory agencies.  

• Act as delegate to Commercial Product Quality   Head , as neede d  

Knowledge, Experience and Skills:   

• In-depth   understanding of   cGMP principles   and   applicable regulatory guidelines and directives ( e.g. ,   ICH , EP,   JP,USP , 21 CF R)<]]>