Senior Manager, Quality Assurance- Medical Device & Combination Products

About this role

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 Description   We are seeking an experienced and highly motivated Senior Manager, QA to support site manufacturing operations as they pertain to the development and commercialization of new combination products. This role offers an exciting opportunity that will be key to Gilead's success as we advance new modalities such 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 and combination 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 inspections • Lead 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 required • Review 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 reviews

Basic 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 oversight • Strong 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 210/211 • Demonstrated in-depth knowledge of Quality principles, concepts, industry practices, and standards • Strong project management and process improvement skills • Prior involvement with Notified body audits or FDA device inspection is preferred • Ability to operate in a matrixed, fast-paced environment with evolving regulatory expectation

  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, visit: https://www.gilead.com

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