Quality Assurance Specialist III

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 As the Quality Assurance Specialist III - Global Product Distribution & Affiliates, your key responsibilities will be: Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as part of a QA team supporting Gilead’s global logistics operations. Serves as a project lead within the function or QA representative on cross functional projects. Maintains routine programs and processes to ensure high quality products and compliance with EU & FDA current Good Distribution Practice (GDP) and National Association of Boards of Pharmacies (NABP) Verified-Accredited Wholesale Distributors (VAWD) requirements. Supports Global and Regional QA teams as well as working cross-functionally with Global Logistics (Commercial & Clinical), Global Supply Planning, Warehouse, Customer Service personnel as well as Trade Operations, Regulatory Affairs and Validation/Packaging Engineering colleagues in all aspects of product distribution. Interfaces with and provides QA oversight of contracted 3PL activities pertaining to product distribution and process performance issues. Participates in developing Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met. Reviews shipping records, environmental monitoring and associated data relating to product distribution activities. Co-hosts/supports external FDA/NABP inspections and internal audit programs. Participates in the development & delivery of training programs relevant to Global product Distribution. Conducts or serves as a coordinator of investigations and corrective and preventive action (CAPA) recommendations as well as Change Management related to QA Operations. Conducts gap analyses and risk assessments of processes & procedures against relevant GDP guidelines as well as corporate standards. Participate in or where relevant lead local and corporate projects and process improvement initiatives, as required. Knowledge, Skills & Competencies Demonstrates in-depth understanding and application of Global GDP principles, concepts, best practices and standards. Experience in Global Product storage & distribution, including cold chain and Ultra-Low Temperature materials. Experience in providing QA oversight of contracted 3PL activities. Demonstrates extensive knowledge of industry best practices and trends. Demonstrates excellent verbal, written, and interpersonal communication skills, as well as excellent influencing skills. Is comfortable interacting with regulatory agencies as needed and possesses the ability to represent Gilead in public forums. Demonstrates the ability to identify, understand and exceed customer expectations. Demonstrates the ability to initiate and support change and respond to change requirements by continually striving to improve process or business areas, consistent with organizational strategy. Basic Qualifications: 5+ Years with BS/BA OR 3+ Years with MS/MA Preferred Qualifications: 6+years of relevant experience and a Bachelor’s degree in science or related fields, or 4+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA. Comprehensive knowledge and experience in quality assurance in highly regulated distribution environments. Broad experience across areas like customer service, warehouse operations, logistics & transport required and understanding of Oral Solid Dosage, Parenteral and Aseptic operations is beneficial. 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. 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. 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. The salary range for this position is: $117,895.00 - $152,570.00. 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 [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 PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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.Apply Now

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