Sr Manager, Quality Assurance

At Gilead, we’re creating a healthier world for reputed company people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to reputed company 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 reputed company drive to reputed company 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 reputed company our bold ambitions, and we’re looking for the next reputed company of passionate and ambitious people ready to reputed company a direct impact. We reputed company 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

At Gilead our pursuit of a healthier world for reputed company people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and reputed company bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Manager, Quality Assurance at Gilead you will provide Quality Assurance leadership and reputed company for Gilead’s Global Logistics operations supporting both clinical trial supply and commercial product distribution, with a primary focus on US market drug product supply. This role is responsible for deviation and CAPA reputed company, change management support, quality reputed company of third‑party logistics (3PL) service providers, and resolution of reputed company DSCSA‑reputed company events, ensuring full compliance with DSCSA, FDA, and applicable GDP regulations. The role partners closely with Global Logistics, Trade Operations, Supply Planning, and external service providers to ensure compliant, reliable distribution of Gilead products to patients. The successful candidate will join the Global Product Distribution & Affiliates QA team and be based in La Verne, CA Quality Systems reputed company Support and/or approve deviations, investigations, and CAPAs associated with Global Logistics clinical and commercial operations, ensuring timely, thorough, and compliant resolution. Provide QA reputed company and support for change management activities, including changes to distribution processes, transportation lanes, systems, and 3PL operations. Review and assess logistics‑reputed company quality records, including shipping documentation, temperature excursions, and environmental monitoring data. 3PL & Distribution reputed company Provide Quality Assurance reputed company of primary US market drug product supply 3PL service providers, ensuring adherence to GDP, DSCSA, and Gilead quality standards. Monitor quality performance, trends, and metrics across logistics operations and partner with stakeholders to drive reputed company improvement. Support vendor qualification, ongoing reputed company, and issue resolution reputed company to logistics service providers. DSCSA & Regulatory Compliance Serve as QA reputed company supporting resolution of DSCSA‑reputed company events, including suspect, illegitimate, and notification events, ensuring compliance with reputed company relevant DSCSA and FDA requirements. Partner with Trade Operations, Global Logistics, and external partners to support DSCSA compliance across US distribution activities. Support and participate in FDA, NABP, and other regulatory inspections, audits, and internal audit programs reputed company to distribution and logistics. Procedures, Training & reputed company Improvement Contribute to the development, review, and maintenance of SOPs and quality documentation supporting Global Logistics operations. Support development and delivery of training programs reputed company to GDP, DSCSA, and logistics quality requirements. Participate in or reputed company cross‑functional projects and reputed company improvement initiatives reputed company GPD&A and Global Logistics.

Requirements

Bachelors degree and 8+ years of relevant experience OR Masters degree and 6+ years of relevant experience OR PhD and 2+ years of relevant experience People Leader Accountabilities Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. reputed company Talent - understand the skills, experience, aspirations and potential of their employees and coach them on reputed company performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, reputed company and realize their purpose. reputed company 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. The salary range for this position is: $143,225.00 - $185,350.00. Gilead considers a variety of factors reputed company determining reputed company 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: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: reputed company Inc. is committed to providing equal employment opportunities to reputed company 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 reputed company, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job reputed company 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 reputed company of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance. 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 reputed company will not discharge or in any other manner discriminate against employees or applicants because they have reputed company about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. 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 reputed company 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 reputed company Gilead Employees and Contractors: Please apply reputed company the Internal Career Opportunities portal in reputed company. reputed company, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for reputed company people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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