Jobs in Santa Monica, CA

About the role

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. 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.

What you'll bring

• Demonstrated experience applying science- and risk-based approaches to product quality, including control strategy, comparability, and lifecycle management.
• Solid knowledge of drug substance and drug product development, manufacturing processes, and associated quality considerations.
• Experience working in cross-functional teams within a matrix environment, with the ability to influence decisions without direct authority.
• Proven ability to lead or contribute to complex product/program activities, including regulatory filings, product quality assessments, and lifecycle management.
• Experience supporting inspections (e.g., PAI/PLI) and interacting with regulatory agencies.
• Strong technical and analytical skills, with the ability to interpret complex product and process data and translate insights into risk-based decisions.
• Ability to   identify, assess, and communicate product quality risks and drive   appropriate mitigation   strategies.
• Effective problem-solving skills, including developing practical, patient-focused solutions to complex quality issues.
• Strong written and verbal communication skills, with the ability to clearly convey complex quality and technical information to cross-functional teams, leadership, and regulatory agencies.
• Ability to   operate   independently, manage multiple priorities, and make sound decisions in a fast-paced environment.
• Prior   Quality   leadership and technical   management   experience   in development   and /or   commercial   programs.
• 12+   years of relevant experience and a   Bachelor ’ s   degree in science   or related fields

Benefits

Locations