Associate Director, QA Compliance

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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.
 

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Job Description
 

The Associate Director- QA Compliance, will report to the Director of Supplier Management and Auditing.  This key position will conduct GMP audits of Gilead’s global suppliers with a primary focus on external biologics manufacturing, contract packaging and contract testing labs. This position will lead audits to support the effectiveness of the global audit program and will work closely with cross functional partners and internal stakeholders.

• Primarily conduct global vendor audits for contract manufacturing of Gilead Biologics 
• Support and/or conduct audits of providers of raw materials, product contact consumables, contract manufacturing or testing, software, warehouse / distribution in support of Gilead’s clinical and commercial oral and parenteral dosage formulations and associated medical devices as assigned.
• Manage all aspects of the audit lifecycle including scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA/PA, and closing.
• Ensure CA/PA to address compliance concerns identified during audits are commensurate with current biologics industry practices and benchmarks
• Ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team.
• Work directly with Gilead cross-functional departments to gather key information and feedback prior to conducting vendor audits in order to …