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

Essential Duties and Job Functions :

• Act as the Sanitary Responsible Deputy Person in front of the Health Authorities for Gilead Sciences Mexico.
• Serve as QA subject matter expert in external audits.
• Manage business strategies regarding product distribution, testing and release.
• Oversee GMP suppliers and Gilead ́s Mexico Warehouse Quality System to ensure GMP and GDP compliance.
• Manage Quality Systems indicators : CAPA, Change Control, Internal and External Deviations, Complaints. Identify and escalate compliance gaps across quality systems.
• Own the Quality Management Review (QMR) process, ensuring compliance with regulatory requirements applicable and opportunely communication of site metrics to senior management.
• Support implementation of Quality Strategy for Gilead Mexico.
• Develop and maintain an effective working relationship with all team members and external stakeholders.
• Support and / or manage local investigations, ensure proper corrective and preventive actions (CAPAs) are implemented and effective.
• Support and / or manage local Change Control processes to ensure proper change an impact assessment is performed, and tasks are implemented.
• Collaborate with cross-functional areas to ensure timely implementation of quality records.
• Responsible for procedures issuance and updates for ensuring alignment to operations.
• Coordinate Import Permits with 3PL ensuring licenses are available for opportunely Drug Product, Reference Standards and Samples importation.
• Support Method Transfer and actions required for New Product Launches.
• Manage internal site audits ensuring adherence to audit schedule and timely closure of findings.
• Additional duties as assigned.

Specific Responsibilities :

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