Associate Director, Quality Assurance

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
 

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

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 across our teams that are committed to the successful delivery of safe life-changing therapies.

Gilead Sciences is currently seeking an Associate Director, External Quality, Clinical Oral Solid Dosage (OSD) to provide quality oversight of GMP activities at assigned Gilead CXOs, supporting the manufacture of small molecule intermediates, drug substances (DS) and drug products (DP) for clinical distribution. This is an independent contributor role who ensures Gilead’s CXOs and clinical programs are proactively led and managed from a quality and compliance perspective and there are no delays to clinical trials. The candidate must have direct experience of overseeing contract manufacturing organizations. The successful candidate must also be extremely knowledgeable of and have a proven track record in clinical development, phase appropriate cGMP application from first-in-human through commercialization, and applicable regulations and requirements.  The candidate must possess strong communication, influencing and negotiation skills and be able to evaluate options, risks, and trade-offs.

Key Responsibilities:

• Primary Pharmaceutical Development and Manufacturing (PDM) Quality contact accountable for proactive quality oversight for assigned clinical CXO partners/sites and programs.

• Assure CXOs meet Gilead’s quality, regulatory and compliance standards, to ensure sustainable delivery of clinical products to patients.

• Reviews and approves DS and DP manufacturing batch records, change controls, and deviations to ensure timely disposition of DP intended for human clinical use.

• Integrates acquired clinical assets and serves as Quality Site Lead (QSL) for assigned CMOs and Alliance Partners.

• Leads Quality Agreement implementation and updates with CMOs.

• Key member of Business Review Meetings with CXO as Quality’s voice for the contract organizations’ oversight.

• Ensure contract manufacturers are compliant and ready for regulatory inspections and monitor progress during inspection. Support onsite inspections to ensure compliance and readiness, as needed.

• Partner with internal stakeholders such as Global External Manufacturing, Global Clinical Supply Chain, Pharmaceutical Development, and Reg CMC, to deliver on the production plan, identify solutions and processes, and align with key partners on implementation of new requirements; proactively address.

• Lead escalations and Material Review Boards for critical quality issues.

• Evaluate current quality systems and processes and recommend and implement appropriate enhancements and training to ensure the achievement of Gilead long-term objectives.

• Monitor CXO site trends, holding CXO accountable to established performance criteria and QAG requirements.

• Ensure GMP documentation is accurate and compliant with internal and external standards and requirements.

• Provide guidan