Gilead Sciences, Inc.
Director, Quality Assurance Compliance/Auditor
Gilead Sciences, Inc., Foster City, California, United States, 94420
Director, Quality Assurance Compliance/Auditor
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.
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 Description
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 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 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 riskConduct due diligence assessments as part of global expansion as requiredIdentify and drive biologics audit program improvements and meet all required metrics and assigned goalsTravel (Domestic and International) may be required up to 40%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 principles 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 beneficial.
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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.
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 Description
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 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 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 riskConduct due diligence assessments as part of global expansion as requiredIdentify and drive biologics audit program improvements and meet all required metrics and assigned goalsTravel (Domestic and International) may be required up to 40%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 principles 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 beneficial.
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