Associate Director, Quality Assurance

Gilead Sciences•Foster City, CA

About The Position

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.

Requirements

Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD/PharmD and Five Years' Experience
Knowledgeable in quality requirements pertaining to small molecule OSD manufacturing, testing, packaging, labeling, facility, utility, equipment and process qualification, new product introduction, contract operations, product release, disposition, and distribution.
In-depth understanding and application of cGMP principles, concepts, best practices, and standards (US and internationally) as applicable to both clinical DS and DP (OSD).
Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
Knowledgeable in Global requirement/standards for product registration.
Demonstrated ability to develop solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist.
Excellent verbal, written, and interpersonal communication skills.
Expert in prioritizing workload to address competing projects and timelines.
In-depth knowledge of technical and regulatory requirements pertaining to clinical small molecule manufacturing, testing, release, and outsourced operations is a must.
Biopharmaceutical or Pharmaceutical experience is a must.
Prior experience leading contract manufacturing/testing operations or overseeing contract manufacturing operations a must.
Broad experience across several areas like CMO QA, drug development, packaging/labeling, and deep understanding of clinical OSD (DS and DP) is a must.

Nice To Haves

Prior people management experience is a plus.

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 guidance to the business teams on regulatory requirements and assist where needed.
Establish and foster meaningful Quality to Quality relationships between Gilead and CXOs.
Conduct regular review and assessment of regulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion.
Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations.
Champion Quality Risk Management, identifying key risks impacting CXO performance.
Travel to CXO site(s) to provide Quality oversight of critical manufacturing activities, as required.

Benefits

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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