For Current Gilead Employees and Contractors:

　　Please log onto your Internal Career Site to apply for this job.

　　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.

　　We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

　　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. Join Gilead and help create possible, together.

　　Job Description

　　Job Responsibilities

　　• Ensures that a compliant Quality Management System is established and maintained in conformity with applicable company and Anvisa regulatory requirements, standards, guidance and procedures.

　　Ensure the QC laboratory operates in compliance with the test methods and product specifications as well as with applicable GMP regulation.

　　Oversees a team of QA and QC specialist.

　　• Ensures the implementation of a Training program that covers on boarding and continuous GDP training

　　• Supports self-inspection and external audits as needed.

　　• Leads continuous improvement efforts in quality systems and department infrastructure through the evaluation of trends in key performance indicators, audit feedback, and corrective and preventative actions.

　　• Represents QA in site management teams and continuous improvement initiatives. Ensures the evaluation, trending, and communication of quality data and information for management review. Chairs Quality Review Board meetings.

　　• Provides cGMP/ GDP guidance to internal departments as applicable. Participates and represents QA project team meetings and discussions.

　　• Ensures efficient and effective QA support for product distribution, testing and disposition of finished product.

　　• Develops plans and implements actions to ensure that the sites operate in conformity with cGMP and cGDP expectations. Ensures site readiness for regulatory and quality inspections.

　　• Define KPI´s and communicate in a timely manner

　　• Oversees the performance of all deviation investigations; ensures robust corrective actions are identified and implemented.

　　• Suports timely and robust OOS investigation

　　• Establishes and maintains systems for the quality oversight of outsourced operations (e.g. contracted laboratories, distribution services).

　　• Oversight of site quality risk assessment and mitigation plans, local quality agreements and APQR´s

　　• Acts as the Quality culture ambassador of the affiliate

　　• Provides QA support for the review and approval of method validation protocols and reports, equipment qualification, product specification and change control documentation.

　　• Provides support to site validation activities.

　　• Assists in the preparation and review of product regulatory submissions and variations to the local health authority.

　　• Support as needed Anvisa’s international inspections to the manufacturing sites.

　　• Oversees investigation and appropriate reporting for customer complaints

　　• Holds Technical responsibility of Gilead Sciences Brazil. (Technical responsible)

　　• Acts as the Subject Matter Expert for the Brazilian market as part of Global technical discussions as required.

　　• Oversees the Quality Budget of the affiliate.

　　10 years of experience in Quality area of pharmaceutical companies

　　· Previous experience with Quality Control laboratory management.

　　· Hands on attitude

　　· Deep understanding of Brazilian GMP/GDP regulations

　　· Ability to manage a team in different locations.

　　· Travel 20% nationally and internationally.

　　· English fluent

　　For Current Gilead Employees and Contractors:

　　Please log onto your Internal Career Site to apply for this job.

　　Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.