Senior Manager, Quality – Combination Products, Compliance

Role Summary

Senior Manager, Quality – Combination Products, Compliance at Gilead La Verne site. Lead quality compliance for combination products, ensuring the QMS supports these products and adherence to global regulations.

Responsibilities

• Monitor medical device standards for QMS updates to ensure adherence to global regulations
• Monitor enforcement trends for device/combination products and develop action plans for QMS improvement
• Participate in external industry committees to ensure regulatory compliance
• Develop and roll out device standards lists by product types and families
• Coordinate process mapping and change for the development, revision, and maintenance of SOPs, job aids, and WI‚Äôs
• Engage with stakeholders across functions when creating/revising QMS processes
• Lead gap assessments against new regulations and inspectional observations; perform impact assessments
• Evaluate medical device reports (MDRs) and justify regulatory decisions
• Support inspection readiness activities and regulatory inspection responses
• Assist with internal and external audits and inspections as SME
• Support combination product complaints investigations and relay findings to design/development
• Evaluate QA information for analysis and risk prioritization
• Compile and analyze data, metrics, and trends for combination product processes
• May manage Quality personnel (contract or FTE), including task prioritization, training, and performance reviews

Qualifications

• Master‚Äôs degree in Science or Engineering with 6+ years of relevant medical device manufacturing/testing/QA experience
• OR Bachelor‚Äôs degree in Science or Engineering with 8+ years of relevant experience

Preferred Qualifications

• Experience with combination devices (e.g., autoinjectors, co-packaged kits, pre-filled syringes)
• In-depth knowledge of quality principles, industry practices, and standards
• End-to-end lifecycle QMS management familiarity
• Strong project management and process improvement skills
• Understanding of U.S. and international quality systems regulations
• Knowledge of 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366
• Know-how of Six Sigma, DMAIC, and quality metrics
• Knowledge of ISO 14971 risk management tools (e.g., HACCP/FMEA) preferred
• ASQ certification (CQA, CQE, or CQM) or equivalent preferred

Skills

• Quality systems management
• Regulatory compliance for medical devices and combination products
• Documentation, SOP development, and process improvement
• Risk assessment and data analysis
• Internal and external audit support
• Stakeholder collaboration across functions