Senior Manager, Quality Assurance- Medical Device & Combination Products

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 DescriptionWe are seeking an experienced and highly motivated Senior Manager, QA to support site manufacturing operations as they pertain to the development andcommercialization of new combination products. This role offers an exciting opportunity that will be key to Gilead's success as we advance new modalitiessuch as pre-filled syringes, auto injectors and co-packaged kits.This role is critical to ensuring a high-quality standard for product quality, regulatory compliance, and industry best practices for medical device andcombination products, with a strong emphasis on pre-filled syringes (PFS) manufacturing at the Gilead La Verne site.The ideal candidate brings hands-on experience in medical device and combination product quality, including ISO 13485, sterile drug product manufacturing, and device / container-closure systems, with proven leadership experience in a GMP-regulated environment. We set and achieve bold ambitions in our fight against the world’s 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.Job Responsibilities:Provide hands-on leadership for pre-filled syringe manufacturing including aseptic manufacturing, visual inspection, device assembly and packaging.Ensure site compliance with ISO 13485, FDA, EMA, and applicable global regulations for drug-device combination products.Serve as subject matter expert for pre-filled syringes and medical device quality, including, container-closure integrity, functional performance and device-specific risk controls.Support technology transfers, equipment qualifications, and validation activities related to PFS and combination products.Collaborate cross‑functionally with, manufacturing, engineering, QC, supply chain, and Regulatory Affairs and Global Central QA to proactively identify and resolve quality risks.Monitor medical device standards for quality management system (QMS) updates to ensure ongoing adherence.Monitor device/combination product regulatory trends in the industry and translate into site-level QMS improvement.Support medical device and combination product inspectional readiness activities and regulatory inspectionsLead and support gap assessments against new regulations and relevant inspectional observations and develop mitigation strategies.Assist with internal and external audits and inspections, acting as an SME and providing follow-up support as requiredReview and approve SOPs, job aids, work-instructions, validation protocols/reports, risk assessments, trend reports and other controlled documents.Support medical device and combination product complaints process and investigations and relay findings to the design and development team.May provide functional leadership and mentoring to Quality personnel, including organizing and prioritizing daily tasks, conducting training, and writing performance reviewsBasic Qualifications:Master’s degree in a Science or Engineering field with 6+ years of direct hands-on experience with medical device manufacturing, testing or QA experience OR Bachelor’s degree in a Science or Engineering field with 8+ years of direct hands-on experience with medical device manufacturing, testing or QA experience.Preferred Qualifications:Strong working experience with medical device and combination products manufacturing is required (e.g., pre-filled syringes, autoinjectors, co-packaged kits)Demonstrated hands-on experience with PFS: design, assembly, inspection, validation or supplier oversightStrong working experience on ISO 13485, ISO 13485, ISO 14971, IEC 62366.Knowledge of ISO 14971 Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and/or FMEA is preferred.Strong working knowledge of Annex 1 and 21 CFR 210/211Demonstrated in-depth knowledge of Quality principles, concepts, industry practices, and standardsStrong project management and process improvement skillsPrior involvement with Notified body audits or FDA device inspection is preferredAbility to operate in a matrixed, fast-paced environment with evolving regulatory expectationThe salary range for this position is: $143,225.00 - $185,350.00. 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 View email address on click.appcast.io for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTGilead 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.SummaryLocation: United States - California - La VerneType: Full time