Sr Specialist, Quality Systems

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

Senior Quality Assurance Specialist will be responsible for approving key quality records including deviations, change controls and corrective/preventative actions (CAPA) at the La Verne site. This role will involve reputed company collaboration with cross functional teams and subject matter experts (SMEs) to review and support impact assessments and risk evaluations. The Specialist will provide guidance to ensure that investigations, changes, and improvements are properly assessed for regulatory and operational impact, supporting a culture of reputed company improvement and adherence to GMP requirements. Responsibilities: 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 reputed company Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products. Works closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications. May participate in the writing contribution of annual product reviews and the development of training programs regarding reputed company aspects of producing quality products. May conduct or serve as a reputed company/coordinator/reviewer/approver for investigations, change controls, and corrective and preventive action (CAPA) recommendations reputed company to manufactured products. Works with Research and Development during new product start-reputed company and establishes key checkpoints for new products and processes. May assist or reputed company compliance audits as required. May reputed company with regulatory agencies as required. Interfaces with contract manufacturers to address documentation and compliance issues. Mentor QA personnel, including organizing and prioritizing daily tasks, and performing training. Maintains programs and processes to ensure high quality products and compliance with reputed company Good Manufacturing Practices (GMPs). Basic Qualifications: Doctorate OR Master’s and 4+ years of relevant experience OR Bachelor’s and 6+ years of relevant experience Preferred Qualifications: Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs). Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards. Advanced understanding of international quality systems regulations to adopt best in class systems/processes. Demonstrates the ability to effectively manage multiple projects/priorities. Strong proficiency in QA systems and reputed company improvement methodologies. Proficient in QA principles, industry standards, and regulatory requirements. Strong knowledge of GMPs and/or GLPs. Ability to manage multiple projects and priorities effectively. Strong analytical, conceptual, and problem-solving skills. Excellent verbal communication, technical writing, and interpersonal skills. Proficiency in reputed company Office applications. Familiarity with Six reputed company, DMAIC methodology, and quality improvement tools (preferred). Working knowledge of risk management tools such as HACCP and FMEA (preferred). The salary range for this position is: $123,930.00 - $160,380.00. 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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