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Principal Auditor - QA Compliance

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: January 23, 2023

Job Description:

Principal Auditor - QA Compliance
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

The Principal Auditor - QA Compliance, - will report to the Senior Director of Supplier Management and Auditing. This key position will lead a small team of auditors and conduct GMP audits of Gilead's global suppliers such as contract manufacturing, contract packaging and labeling, and contract testing labs. This position will lead activities that will support the effectiveness of the global audit program and will work closely with each of the GMP/GDP various functions and stakeholders at Alberta, Cork, Foster City, Oceanside, San Dimas/LV, and New Jersey.

The main responsibilities are:

  • Managed and supervised a small team of professional auditors that conduct global vendor audits for Gilead GMP providers of raw materials, product contact consumables, contract manufacturing or testing, software, warehouse / distribution in support of Gilead's clinical and commercial oral, biological and parenteral dosage formulations and associated medical devices as assigned.
  • Conduct and 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 that the audit agenda from the team 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.
  • Ensure completion of correct CA/PA to address compliance concerns identified during audits.
  • 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 commercial and clinical manufacturing platform 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 wiring, classification, status, and overall risk
  • Manage and drive accuracy of the approved CMO/CTL vendor list and ensure that the information for the vendor is accurate in GTrack
  • Conduct due diligence assessments as part of global expansion as required
  • Identify and drive program improvements and meet all required metrics and assigned goals
  • Other responsibilities as required.
    Travel is required up to 30%

    Essential Functions:
    • Supports Compliance management in maintaining the company's Compliance program.
    • 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 compliance requirements and responsibilities within the function.
    • 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:
      • 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.
      • 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.
      • Managerial experience of leading small team of professionals is a plus.
      • 15+ years of relevant experience in the pharmaceutical industry and a BS or BA in a relevant field of study.
      • 12+ years of relevant experience and a MS in a relevant field of study.
        Desirable:
        • Working knowledge and experience in the Biological and Aseptic Manufacturing industry.
        • 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.
        • Japanese GMPs
        • Skilled auditor with 15 years of experience and ability to perform investigative audits.

          For jobs in the United States:

          As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

          Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

          For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

          NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
          YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

          PAY TRANSPARENCY NONDISCRIMINATION PROVISION

          Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

          Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

          For Current Gilead Employees and Contractors:

          Please log onto your Internal Career Site to apply for this job.

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Keywords: Gilead Sciences, Inc., San Mateo , Principal Auditor - QA Compliance, Accounting, Auditing , San Mateo, California

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