QA Senior Specialist - External Quality, Strategy, Processes and Metrics

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 DescriptionResponsibilities:The responsibilities of theSenior QA Specialist is to maintain commercial product specifications current in all GMP systems, as well as the management of SAP workflow to ensure compliance to product dossiers and enable timely release of products. Lifecycle management of specification include revisions based on feedback from health authorities during post approval changes and submission of a commercial products to additional countries, or from continuous process verification where a change to approved specification is warranted.TheSenior QA Specialist needs to manage change control record in GVault pertaining to specification revision, and must be well verse in using the SAP system. Knowledge with specification setting and experience with assisting the response to health authority inquiries related to specifications are beneficial. Specific Education & Experience Requirements: 7+ years of relevant experience in a GMP environment related field and a BS or BA. 5+ years of relevant experience and a MS. Preferred Requirements: Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met.Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs). May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products. May assist or lead compliance audits as required. May interface with regulatory agencies as required. Interfaces with internal sites and contract manufacturers to address inquires from health authorities during product submission and post approval changes.Proficient in application of QA principles, concepts, industry practices, and standards. Demonstrates ability to effectively manage multiple projects/priorities. Has proven analytical and conceptual skills. Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes. Demonstrates excellent verbal communication, technical writing and interpersonal skills. Demonstrates working knowledge and good proficiency in Microsoft Office applications. Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial. Knowledge with IND/NDA/BLA submission process is desired. The salary range for this position is: $136,340.00 - $176,440.00. 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: * 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 'KnowYour 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 InternalCareer 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 tot his job