Senior Manager, Quality – Combination Products, Compliance

Role Summary

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.

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

Qualifications

• Required: Master’s degree in a Science or Engineering field with 6+ years of relevant experience with medical device manufacturing, testing or QA experience. OR Bachelor’s degree in a Science or Engineering field with 8+ years of relevant experience with medical device manufacturing, testing or QA experience.
• Preferred: Experience with combination devices (e.g., autoinjectors, co-packaged kits, pre-filled syringes)
• 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., HACCP and/or FMEA is preferred)
• Certification by ASQ (such as CQA, CQE, or CQM) or other industry-recognized professional organizations is preferred