Gilead Sciences, Inc.
Associate Director, Clinical Operations- Quality & Compliance
Gilead Sciences, Inc., Foster City, California, United States, 94420
Associate Director, Clinical Operations- Quality & Compliance
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 DescriptionThe Clinical Trial Capabilities (CTC) organization offers infrastructure, support, and solutions enabling the Clinical Operations and Development Organizations with rapid, efficient, and compliant clinical trial execution to deliver transformative medicines to patients. The Connect function within the CTC organization is a centralized process department that specializes in process improvements, procedural documents, and quality and inspection readiness for Clinical Operations.The Associate Director will be a key member of the Connect Quality team and collaborate with Clinical Operations personnel to ensure quality, proactively identify risk, mitigate non-compliance, and support inspection readiness activities. The position will partner closely with Research & Development Quality personnel.Primary Responsibilities:Lead efforts to increase a culture of quality within the Clinical Operations organization.Develop, deploy and maintain Inspection Readiness activities for key programs within Clinical Operations.Provide ongoing support, guidance, consultation pre, during and post inspection readiness phases.Partner with clinical study teams on risk identification/management/mitigation activities.Gather, analyze and share best practices and lessons learned from audit, inspection, deviation activities.Work with relevant stakeholders to identify areas for improvement from audits, inspections, deviations, and corresponding appropriate next steps.Compile and communicate quality related metrics, risks, and quality challenges to teams and management.Provide guidance for investigations, root cause analysis, as well as development of corrective and preventive action (CAPA) plans for deviations and/or observations of non-compliance.Maintain awareness of changes within the industry and regulatory environment to ensure Clinical Operations alignment.Determine, develop, execute Effectiveness Checks for applicable CAPAs.Coordination of Clinical Operations internal process audit activities.Lead activities pertaining Clinical Operation internal deviations.Create and deploy procedure to conduct compliance checks for designated processes.Qualifications:BA or BS and 10+ years’ experience in compliance in pharmaceutical/biotechnology industry.Excellent working knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.Direct experience at the Sponsor level with front and back room inspection operations.Ability to build strong relationships to foster a collaborative approach to proactive compliance activities.Key stakeholders include clinical systems, TMF, RBQM, Vendor quality/oversight, thus direct experience with those areas preferred.Strong verbal, written, communication, and interpersonal skills.Ability to analyze complex situations, develop multiple options/solutions within regulatory guidance.The salary range for this position is: $191,335.00 - $247,610.00. 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, paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeingAs 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.
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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 DescriptionThe Clinical Trial Capabilities (CTC) organization offers infrastructure, support, and solutions enabling the Clinical Operations and Development Organizations with rapid, efficient, and compliant clinical trial execution to deliver transformative medicines to patients. The Connect function within the CTC organization is a centralized process department that specializes in process improvements, procedural documents, and quality and inspection readiness for Clinical Operations.The Associate Director will be a key member of the Connect Quality team and collaborate with Clinical Operations personnel to ensure quality, proactively identify risk, mitigate non-compliance, and support inspection readiness activities. The position will partner closely with Research & Development Quality personnel.Primary Responsibilities:Lead efforts to increase a culture of quality within the Clinical Operations organization.Develop, deploy and maintain Inspection Readiness activities for key programs within Clinical Operations.Provide ongoing support, guidance, consultation pre, during and post inspection readiness phases.Partner with clinical study teams on risk identification/management/mitigation activities.Gather, analyze and share best practices and lessons learned from audit, inspection, deviation activities.Work with relevant stakeholders to identify areas for improvement from audits, inspections, deviations, and corresponding appropriate next steps.Compile and communicate quality related metrics, risks, and quality challenges to teams and management.Provide guidance for investigations, root cause analysis, as well as development of corrective and preventive action (CAPA) plans for deviations and/or observations of non-compliance.Maintain awareness of changes within the industry and regulatory environment to ensure Clinical Operations alignment.Determine, develop, execute Effectiveness Checks for applicable CAPAs.Coordination of Clinical Operations internal process audit activities.Lead activities pertaining Clinical Operation internal deviations.Create and deploy procedure to conduct compliance checks for designated processes.Qualifications:BA or BS and 10+ years’ experience in compliance in pharmaceutical/biotechnology industry.Excellent working knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.Direct experience at the Sponsor level with front and back room inspection operations.Ability to build strong relationships to foster a collaborative approach to proactive compliance activities.Key stakeholders include clinical systems, TMF, RBQM, Vendor quality/oversight, thus direct experience with those areas preferred.Strong verbal, written, communication, and interpersonal skills.Ability to analyze complex situations, develop multiple options/solutions within regulatory guidance.The salary range for this position is: $191,335.00 - $247,610.00. 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, paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeingAs 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.
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