Associate Director, QA Compliance

Descrizione del lavoro

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 ensure effectiveness.
• 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
• Conduct due diligence assessments as part of global expansion as required
• Identify and drive biologics audit program improvements and meet all required metrics and assigned goals

Travel is required up to 50%

Essential Functions:

• 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.

Knowledge, Experience & Skills:

Essential:

• Extensive background in Biologics Operations (e.g. Manufacturing, Quality Control, Quality Assurance)
• Demonstrates excellent verbal, written, and interpersonal skills.
• 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; EudraLex Volume 4 and applicable annexes; and Health Canada R.S.C., 1985, F-27, Section 30; as well as ICH, ISO, PIC/S and USP/NF, EP, and JP compendial standards and principals as applicable.
• Skilled auditor with 10 years of experience and ability to perform investigative audits
• Is capable of taking a leadership role in updating and preparing the company for changes in regulations.
• 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.
• 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.