<p>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.</p> <p>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.</p> <p>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.</p> <p>Job Description</p> <p>Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.</p> <p>We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career. Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?</p> <p>KEY RESPONSIBILITIES:</p> <p>GCP Audit Program Leadership</p> <ul> <li>Accountable for the successful oversight and completion of a broad spectrum of GCP audit activities and deliverables across large sites, countries, or multiple regions. </li><li>Lead internal and external R&D quality audits for assigned R&D groups or locations. </li><li>Provide matrix management and leadership to project teams. </li><li>Develop and drive continuous improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals and contribute to the overall quality mindset and culture. </li></ul> <p>GCP Audit Operations</p> <ul> <li>Act as a primary point-of-contact to assigned R&D groups and advise on: GCP regulatory requirements; relevant Gilead policies and procedures supporting audits and clinical activities. </li><li>Evaluate SOPs, other procedures, data and reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance, R&D quality and fit-for-purpose to both Gilead business needs and regulatory requirements. </li><li>Execute the strategic audit plan. Plan, schedule, and conduct GCP audits in accordance with the audit plan. </li><li>Prepare and deliver high quality audit reports and follow up on CAPAs to ensure timely resolution and CAPA effectiveness. </li><li>Lead/Support risk assessment activities, in partnership with risk program and SMEs. </li><li>Support the overall inspection readiness of the GCP Audit program, including preparation and participation for inspections. </li><li>Oversee and manage the work of contractor auditors, ensuring effective oversight and completion of assigned tasks. </li><li>Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables. </li><li>Provide accurate and thorough input and recommendations into resource allocation and budgets. </li></ul> <p>Quality Management</p> <ul> <li>Evaluate, and advise on systems, processes, documentation, and CAPAs for assigned R&D groups to ensure ongoing compliance and alignment with regulatory requirements. </li><li>Play a key role in preparing the assigned R&D groups for inspections or external reviews including ensuring alignment with Gilead business needs and regulatory requirements. </li><li>Support Head of GCP/GLP Audits to implement an Effectiveness Check strategy, in partnership with GVP and E-system/Digital Audit Heads for Audit related CAPAs. </li><li>Stay current with evolving global clinical regulations and guidance. </li><li>Support the development of GCP Audit material/insights for quality forums and management reviews. </li></ul> <p>Training & Development</p> <ul> <li>Develop and deliver on GCP training for assigned R&D groups ensuring teams are equipped with the knowledge and skills to maintain compliance and audit excellence. </li><li>Establish relationships with key stakeholders, including contract auditors, cross-functional leaders, and regulatory teams to facilitate training, knowledge sharing and continuous improvement initiatives. </li></ul> <p>BASIC QUALIFICATIONS:</p> <ul> <li>12+ Years with BS/BA </li></ul> <p>OR</p> <ul> <li>10+ Years with MS/MA or MBA </li></ul> <p>PREFERRED QUALIFICATIONs:</p> <ul> <li>Proficiency in clinical regulatory requirements (Global) is a must. </li><li>Expert-level experience working with GCP processes and systems is required. </li><li>Proficient in GxP Auditing with a successful track record of leading clinical/investigator site audits. </li><li>Broad experience participating in cross-functional projects and teams with responsibilities related to pharmacovigilance and quality system activities. </li><li>Significant experience leading quality, compliance or related projects in the biopharma or related industry, including leading continuous improvements such as new or updated business processes, systems and/or SOPs. </li><li>Significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation. </li><li>Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred. </li><li>Certification as a Quality Auditor is preferred. </li><li>BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, including significant relevant experience working in quality, compliance, pharmacovigilance, or a related field. </li><li>Extensive experience leading GCP audits, in the biopharma or related industry. </li><li>Expert knowledge of the drug development process and GCP, including global regulations (FDA, EMA, ICH) and their application to cross-functional clinical development. </li><li>Proficient in GxP Auditing with a successful track record of leading clinical/investigator site audits. </li><li>Thorough knowledge of standards, systems, policies, and procedures that enable QMS operations and compliance within the biopharma industry, specifically those related to GCP. </li><li>Proven effectiveness in making appropriate decisions independently for relatively complex projects or related issues, as evidenced by past decision-making track record. </li><li>Proven abilities to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development. </li><li>Advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex information and understanding the quality and compliance implications on the portfolio. </li><li>Track record of successful interaction and collaboration with other functions and with senior leadership, on key projects and deliveries supporting quality and compliance. </li><li>Demonstrates ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function. </li><li>Demonstrates ability to integrate varied concepts and data to develop relevant solutions. </li><li>Proven abilities to anticipate problems of varying complexity and lead the resolution of these in a collaborative manner, across functions. </li><li>Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives. </li><li>Strong critical and strategic thinking skill and risk-based mindset. </li><li>Proven track record of successful change management implementation across highly matrixed organizations. </li><li>Ability to travel (up to 20%) </li></ul> <p>People leader accountabilities</p> <ul> <li>Create inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. </li><li>Develop talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. </li><li>Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. </li></ul> <p>The salary range for this position is:</p> <p>Bay Area: $210,375.00 - $272,250.00.</p> <p>Other US Locations: $191,250.00 - $247,500.00.</p> <p>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*.</p> <p>For additional benefits information, visit:</p> <p>https://www.gilead.com/careers/compensation-benefits-and-wellbeing</p> <ul> <li>Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. </li></ul> <p>For jobs in the United States:</p> <p>Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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.</p> <p>For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.</p> <p>NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT</p> <p>YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT</p> <p>PAY TRANSPARENCY NONDISCRIMINATION PROVISION</p> <p>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.</p> <p>Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.</p> <p>For Current Gilead Employees and Contractors:</p> <p>Please apply via the Internal Career Opportunities portal in Workday.</p>