Director, Quality Assurance Compliance/Auditor

Director, Quality Assurance Compliance/Auditor

We are currently seeking an industry leader for a Director, Quality Assurance role, who will report to Executive Director, Supplier Quality Management and Audits, within the Global Quality Systems & Compliance department. The role is highly visible, offers tremendous growth potential, and requires technical acumen, strong leadership, and collaboration with cross-functional stakeholders across QA, Global Supply Chain, Manufacturing Operations and Technical Development.

Essential Duties and Job Functions:

• Leads a team of auditors based in North America
• Demonstrated people leader experience (e.g. Workforce Planning, talent development, Budget adherence experience, promoting an inclusive and collaborative culture of trust and respect)
• Primarily conduct global vendor audits for contract manufacturing of Gilead Contract Manufacturers
• 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.
• Align, strategize and collaborate with the Global Supplier Quality function within Gilead
• Enhance Global Third party Quality Oversight program and Qualification Process by leading initiatives to maintain compliance to global regulations and standards
• Represent the Quality function by developing the program and supporting the selection process for new/preferred suppliers
• Act as liaison between global supplier quality and Gilead’s production facilities
• 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.
• SAP Supplier and Material Master Data experience is a must (e.g. Creation, Maintenance, Governance)
• 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 (Domestic and International) may be required up to 40%

Regulatory Intelligence

• Effectively communicate regulatory trends, insights and implications for Gilead to senior leadership with presentations and written reports
• Respond to queries from internal stakeholders to support inspection readiness, external audits, regulatory submissions and staff training
• Maintain online platforms (e.g., SharePoint) to provide intelligence related to Gilead’s products, internal and external manufacturing and testing sites
• Design and author GMP RI newsletters to arm PDM staff with timely and actionable knowledge by aggregating and distilling information across multiple GMP subscription services, industry consortiums, and open meetings sponsored by health authorities
• Other responsibilities as required to meet business needs

Knowledge, Experience and Skills:

• 12+ years of relevant experience and BS/BA degree; or 10+ years of relevant experience and a MS/MA or MBA degree.
• Extensive background in Biologics Operations (e.g. Supplier Management, 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
• Demonstrated experience to manage staff.
• Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
• Biopharmaceutical or Pharmaceutical experience preferred.
• Broad experience across areas like CMO QA, Validation, Drug development experience and/or Pharmacovigilance and understanding of Parenteral, Aseptic and API operations is beneficial

The salary range for this position is: $205,700.00 - $266,200.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. 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: Gilead Benefits

About Us

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.