Senior Manager, Quality Assurance

For Current Gilead Employees and Contractors:

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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
 

Working in QA at Gilead:

Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through robust QA processes and systems. Our approach is agile, innovative, and collaborative, and our teams are genuinely committed to the rapid delivery of safe life-changing therapies. 

Job Summary:
Gilead Sciences seeks a Sr. Manager, Quality Assurance, in the Pharmaceutical Development and Manufacturing (PDM) organization. The Sr. Manager provides quality and compliance activities for clinical and commercial products and programs.

Job Functions: 

• Serve as QPTL (Quality Product Team Lead) or QA Operational Lead (OL) for assigned programs
• Review and approve change control requests, lab investigations, deviations, and proposed corrective actions and preventative actions (CAPAs) to ensure compliance with Gilead procedures, cGMP, and all other applicable regulations
• Collaborate and escalate as necessary. 
• Generate and or contribute to relevant metrics and annual product quality reports.  
• Review and approve GMP facilities, utilities, and equipment changes.
• Reviews and approves method validation and/or transfer documents including protocols, reports, and methods for small molecules and/or large biologics.
• Review and approve protocols and reports for manufacturing, packaging and labeling unit operations.
• Generate data and contribute/participate at relevant CMC team(s).
• Interact with contract manufacturers/labs, internal Manufacturing Departments, and Analytical Development Operations to resolve quality issues.
• Provide oversight for API and DP Pilot Plants.
• Provide support for QP activities.
• Review existing quality workflows, perform gap assessments, and assist in identifying areas for improvement. 
• Author, revise, and review standard operating procedures.
• Manages QA personnel, including organizing and prioritizing daily tasks, provides training and writing performance reviews
• Responsible for final batch review, approval and release of manufactured products.
• Review manufacturing, packaging, and labeling Drug Product batch records and in-process quality control data and assess the completeness of change controls, deviations, and test results to ensure timely disposition of drug products intended for commercial or clinical use.
• Review API/Drug Substance batch records and in-process data, assess the completeness of change controls, deviations, and test results for timely disposition of API/Drug Substance intended for commercial or clinical use.
• Interact with key stakeholders to ensure that clinical a