Senior Manager, Quality Assurance (GMP Operations)

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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 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 the Sr Manager Quality Assurance - GMP Operations at Gilead, you will provide Quality leadership and direct quality oversight of Manufacturing and Quality Control (QC) at the Foster City site. This role ensures GMP compliance through design, startup, and operation of a new, state-of-the-art Single Use DS Biologics Manufacturing facility and QC Laboratory in Foster City, CA. The position partners closely with Manufacturing and QC teams to enable compliant, risk-based decision making and continuous improvement while maintaining patient safety and product quality. This is a site based role at our facility in Foster City, CA. Knowledge: Demonstrates in-depth knowledge of GMPs and/or GLPs. Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards. Demonstrates excellent verbal, written, and interpersonal communication skills. Demonstrates keen understanding of international quality systems regulations to adopt best in class systems/processes, and drive continuous improvement initiatives. Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements. Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred. Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred. Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred. Specific Job Responsibilities: Manages, prioritizes, and participates in batch record review and release activities, including review of manufacturing, environmental monitoring, and quality control data for in-process and finished products. Responsible for final release of manufactured products. Provide Quality Assurance oversight of external QC laboratories, ensuring method lifecycle activities (qualification, verification, and validation) are executed in compliance with cGMP, ICH, and internal quality standards, with appropriate review and approval of protocols, reports, and methods. Review and approve laboratory investigations (e.g., OOS/OOT/deviations) conducted by contract partners, ensuring thorough root cause analysis, robust corrective and preventive actions (CAPA), and aligned decision-making impacting product quality and disposition. Manages, prioritizes, and reviews quality control data for method establishment, qualification/validation, and transfer. Apply Quality Risk Management principles to oversee risk assessments in collaboration with Manufacturing, and QC operations. Participates in authoring, reviewing, and approving changes to standard operating procedures, specifications, forms, and other controlled documents to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). Participates in and oversees design and planning of new biologics manufacturing facility and QC laboratory. Participates in site inspection readiness activities and internal audits. Participates in continuous improvement initiatives. Partner w

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