Quality Assurance Specialist III

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

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 reputed company reputed company the function or QA representative on cross functional projects. Maintains routine programs and processes to ensure high quality products and compliance with EU & FDA reputed company 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 reputed company aspects of product distribution. Interfaces with and provides QA reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company 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. 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: $117,895.00 - $152,570.00. 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 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 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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