Senior Manager, Quality – Combination Products, Compliance

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 DescriptionThis role offers an exciting and challenging opportunity that will be key to Gilead's success as we advance new combination products, such as vial kits and pre-filled syringes, to market. You will be a key Quality leader responsible for managing compliance for combination products compliance at Gilead La Verne site.We are looking for an experienced Quality professional to ensure that our QMS provides comprehensive support of these combination products.Roles/ResponsibilitiesMonitor medical device standards for quality management system (QMS) updates to ensure adherence to global regulationsMonitor device/combination product enforcement trends in the industry and develop recommendations and action plans for QMS improvementParticipate in external industry committees and ensure compliance with applicable medical device and combination product regulationsParticipate in the development and rollout of device standards lists by product types and familiesCoordinate and lead the process mapping and change for the development, revision, and maintenance of applicable department SOP’s, job aids, and WI’sEngage with stakeholders across various functions when creating/revising QMS processes.Lead gap assessments against new regulations and relevant inspectional observations, and perform impact assessments as requiredParticipate in evaluations of medical device reports (MDRs) and provide documented justifications for reportable and non‑reportable regulatory decisions.Support medical device and combination product inspectional readiness activities and regulatory inspection responsesAssist with internal and external audits and inspections, acting as an SME and providing follow-up support as requiredSupport combination product complaints process and investigations and relay findings to the design and development teamEvaluate information from a QA technical perspective to ensure appropriate analysis and risk prioritizationCompile and analyze data, metrics, and trends associated with combination product processes.May manage Quality personnel (contract or FTE), including organizing and prioritizing daily tasks, conducting training, and writing performance reviewsBasic QualificationsMaster’s degree in a Science or Engineering field with 6+ years of relevant experience with medical device manufacturing, testing or QA experience.ORBachelor’s degree in a Science or Engineering field with 8+ years of relevant experience with medical device manufacturing, testing or QA experience.Preferred QualificationsExperience with combination devices (e.g., autoinjectors, co-packaged kits, pre-filled syringes)Demonstrated in-depth knowledge of Quality principles, concepts, industry practices, and standardsFamiliarity with end-to-end lifecycle QMS managementStrong project management and process improvement skillsDemonstrated keen understanding of U.S. and international quality systems regulations to adopt best-in-class systems and drive continuous improvement initiativesKnowledge of applicable standards, including 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366Preferred knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statisticsKnowledge of ISO 14971 Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and/or FMEA is preferred.Certification by ASQ (such as CQA, CQE, or CQM) or other industry-recognized professional organizations is preferred.The 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, Visithttps://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 StatesGilead 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 ApplicantAccommodations@gilead.com 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 ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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 ContractorsPlease apply via the Internal Career Opportunities portal in Workday.