Associate Director- QA Compliance

Job Description 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.
Join Gilead and help create possible, together.
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. 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.
Participate in the development, implementation, and maintenance of procedures and templates to assist in the evaluation of and in improvement of the auditing process.
Identify compliance risks and escalate issues to appropriate levels of management for resolution.
Promote awareness across the biologics commercial and clinical manufacturing platform(s) of current regulatory agency requirements and trends and develop and report on the trends identified to better focus the scope of audits.
Drive consistency with audit report observation writing, classification, status, and overall risk
Travel is required up to 50%. Supports Compliance management in maintaining the company’s Compliance program.
May manage the day-to-day activities of one or more individual contributors, including task assignment and prioritization, monitoring task performance, and conducting performance reviews.
Ensures awareness of biologics compliance requirements across impacted functional areas
Establishes excellent working relationships with compliance/quality groups.
Responsible for maintaining current knowledge of applicable compliance requirements through attendance at industry and regulatory agency sponsored meetings and seminars and individual self-study including periodic review of all relevant regulations, guidance documents, and requirements.
Responsible for providing guidance on interpretation and application of existing and new requirements. Provide guidance to assigned departments and management when specific compliance issues arise.
Assists in evaluation and implementation of standard operating procedures and systems needed to comply with requirements.
Leads various types of audits or projects or supervises contractors. Audits may include internal systems audits, external vendor audits, or document reviews.
Assists in regulatory agency inspections. Assists in coordination of responses to any regulatory agency findings.
10+ years of relevant experience in the pharmaceutical industry and a BS or BA in a relevant field of study.
8+ years of relevant experience and a MS in a relevant field of study.
Extensive background in Biologics Operations (e.g. Manufacturing, Quality Control, Quality Assurance)
Demonstrates a thorough knowledge of compliance requirements, and an understanding of current global and regional trends in compliance.
Knowledge of domestic and international regulations including 21 CFR Parts 11, 203, 205. 210, 211, 600, 610, 820; Is capable of leading a small team in development of systems and procedures and implementation.
Is well recognized as a knowledgeable resource for QA compliance advice in other departments. Capable of effectively managing a small team of experienced subject matter experts in execution of audits.