Sr Specialist, Quality Systems

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.

Senior Quality Assurance Specialist will be responsible for approving key quality records including deviations, change controls and corrective/preventative actions (CAPA) at the La Verne site. This role will involve close collaboration with cross functional teams and subject matter experts (SMEs) to review and support impact assessments and risk evaluations. The Specialist will provide guidance to ensure that investigations, changes, and improvements are properly assessed for regulatory and operational impact, supporting a culture of continuous improvement and adherence to GMP requirements.

• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
• Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Reviews manufacturing, environmental monitoring and quality control data for in‑process and finished products.
• Works closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications.
• May participate in the writing contribution of annual product reviews and the development of training programs regarding all aspects of producing quality products.
• May conduct or serve as a lead/coordinator/reviewer/approver for investigations, change controls, and corrective and preventive action (CAPA) recommendations related to manufactured products.
• Works with Research and Development during new product start‑ups and establishes key checkpoints for new products and processes.
• May assist or lead compliance audits as required. May interface with regulatory agencies as required.
• Interfaces with contract manufacturers to address documentation and compliance issues.
• Mentor QA personnel, including organizing and prioritizing daily tasks, and performing training.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).

• Doctorate OR
• Master’s and 4+ years of relevant experience OR
• Bachelor’s and 6+ years of relevant experience

• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards.
• Advanced understanding of international quality systems regulations to adopt best in class systems/processes.
• Demonstrate the ability to effectively manage multiple projects/priorities.
• Strong proficiency in QA systems and continuous improvement methodologies.
• Proficient in QA principles, industry standards, and regulatory requirements.
• Strong knowledge of GMPs and/or…