QA Specialist II

At Gilead, were creating a healthier world for all people. For more than 35 years, weve 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 worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gileads 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 were 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 At Gilead our pursuit of a healthier world for all 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 achieve bold ambitions in our fight against the worlds 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 QA Specialist II at Gilead you will provide support for Gileads Global Logistics operations across both clinical and commercial supply chains. This role is responsible for deviation and CAPA review, change management support, and quality oversight of thirdparty logistics (3PL) service providers. The Specialist ensures compliance with global Good Distribution Practice (GDP) requirements and supports consistent, highquality product distribution to global markets. This role is based in Foster City, reporting to the Senior Director, Quality Assurance Global Product Distribution & Affiliates. Quality Systems Support Review and approve deviations, investigations, and CAPA records associated with Global Logistics activities. Support change controls related to distribution processes, transportation lanes, and 3PL operational activities. Conduct quality reviews of distribution and operational documentation (e.g., shipping records, environmental monitoring, temperature excursions). Partner with QA colleagues to ensure compliance with GDP, GMP, and applicable regulatory requirements. 3PL & Distribution Oversight Provide QA oversight of global 3PL partners, including assessment of operational compliance, quality performance, and adherence to Gilead standards. Monitor and review logistics data to identify quality trends or potential process improvements. Contribute to routine quality metrics reporting and partner with Logistics to address identified gaps. Procedures, Audits, and Compliance Participate in development, revision, and maintenance of Standard Operating Procedures (SOPs) related to distribution and logistics operations. Support internal audits and external inspections pertaining to distribution activities. Ensure consistent application of quality policies, procedures, and industry best practices across the logistics network. CrossFunctional Collaboration Collaborate closely with Global Logistics, Supply Chain, Warehouse Operations, Customer Service, Regulatory, and other crossfunctional groups to ensure compliant product distribution. Provide QA input into operational improvements, issue resolution, and process standardization. Requirements Bachelors degree and 4+ years of relevant experience OR Masters degree and 2+ years of relevant experience The salary range for this position is: $102,085.00 - $132,110.00. 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: 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: 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. 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 Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired 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 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 apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, 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 all 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.