Director, Quality Assurance Compliance/Auditor
- Gilead Sciences
- Foster City, MI
Job Description
For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.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 DescriptionWe 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, offer 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 AmericaDemonstrated 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 ManufacturersSupport 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 GileadEnhance Global Third party Quality Oversight program and Qualification Process by leading initiatives to maintain compliance to global regulations and standardsRepresent the Quality function in by developing the program and supporting the selection process for new/preferred suppliersAct as liaison between global supplier quality and Gilead’s production facilitiesEnsure CA/PA to address compliance concerns identified during audits are commensurate with current biologics industry practices and benchmarksEnsure 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 goalsTravel (Domestic and International) may be required up to 40%Regulatory IntelligenceEffectively communicate regulatory trends, insights and implications for Gilead to senior leadership with presentations and written reportsRespond to queries from internal stakeholders to support inspection readiness, external audits, regulatory submissions and staff trainingMaintain online platforms (e.g., SharePoint) to provide intelligence related to Gilead’s products, internal and external manufacturing and testing sitesDesign 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 authoritiesOther responsibilities as required to meet business needsKnowledge, 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 auditsDemonstrated 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 beneficialThe 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. These considerations mean actual compensation will vary. 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: * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.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 ApplicantAccommodations@gilead.com for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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.SummaryLocation: United States - California - Foster CityType: Full time
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