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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
This 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/Responsibilities:
Monitor medical device standards for quality management system (QMS) updates to ensure adherence to global regulations
Monitor device/combination product enforcement trends in the industry and develop recommendations and action plans for QMS improvement
Participate in external industry committees and ensure compliance with applicable medical device and combination product regulations
Participate in the development and rollout of device standards lists by product types and families
Coordinate and lead the process mapping and change for the development, revision, and maintenance of applicable department SOP’s, job aids, and WI’s
Engage 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 required
Participate 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 responses
Assist with internal and external audits and inspections, acting as an SME and providing follow-up support as required
Support combination product complaints process and investigations and relay findings to the design and development team
Evaluate information from a QA technical perspective to ensure appropriate analysis and risk prioritization
Compile 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 reviews
Knowledge, Experience, and Skills:
8+ years of relevant experience with a Bachelor’s degree in a Science or Engineering field; or 6+ years of relevant experience with a Master’s degree in a Science or Engineering field
Medical device manufacturing, testing or QA experience is essential. Experience with combination devices (e.g., autoinjectors, co-packaged kits, pre-filled syringes) is preferred
Demonstrated in-depth knowledge of Quality principles, concepts, industry practices, and standards
Familiarity with end-to-end lifecycle QMS management
Strong project management and process improvement skills
Demonstrated keen understanding of U.S. and international quality systems regulations to adopt best-in-class systems and drive continuous improvement initiatives
Knowledge of applicable standards, including 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366
Preferred knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistics
Knowledge 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.
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.
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