Sunny Gill
Seasoned professional focused on delivering world-class support to the Biopharmaceutical, Pharmaceutical and Medical Device industries.
- Role
- Assoc Director, Quality - Combination Products Compliance at Gilead Sciences
- Location
- Los Angeles, CA, US
- LinkedIn followers
- 500 followers
About Sunny Gill
Seasoned professional with functional management / leadership experience and a demonstrated history of working in the electronics, aerospace, automotive, telecommunications, medical device, biotechnology and pharmaceutical industries. Strong Quality and Process Engineering background; skilled in Risk Management, Process Validation, Quality Management System Standards, Design Controls, Process Improvement and Regulatory Affairs.
Experience
Assoc Director, Quality - Combination Products Compliance
Aug 2024 — Present · La Verne, CA, US
Ensure compliance with applicable global regulations by monitoring external device/combination product enforcement trends, monitoring applicable standards for QMS updates, actively participating on relevant external industry committees and ensuring continuous improvement of QMS. Lead gap assessments and perform impact assessments against new regulations and relevant inspectional observations. Support internal and external audits and inspections, including medical device and combination product inspection readiness activities and regulatory inspection responses. Support combination product complaints process and investigations by coordinating and leading root cause analysis to ensure effective corrective actions for mitigations. Perform MDR evaluations including justifications to support regulatory decisions. Strong collaboration with stakeholders when creating/revising QMS processes and for effective complaint handling/MDR assessments and adverse events with potential product quality issues. Compile and analyze data, metrics, and trends associated with combination product processes and filter information to drive continual improvement.
Education
University of Southern California
BS, Electrical Engineering
1990 — 1992
California State University, Northridge
BS, Biology
1994 — 1995
California State University, Northridge
BA, Economics
1984 — 1988
UCLA
DrPH, Healthcare Mgmt & Policy; Global Health
2007 — 2011
Pepperdine Graziadio Business School
MBA, General Management
1999 — 2001
Skills
- Six Sigma
- Management Consulting
- Supply Chain
- Analysis
- Lean Manufacturing
- Quality System
- Iso 9000
- Program Management
- Supply Chain Management
- Cross-Functional Team Leadership
- Strategy
- Quality Assurance
- Change Management
- Software Documentation
- Root Cause Analysis
- Training
- Quality Control
- Project Management
- Strategic Planning
- Quality Management
- Management
- Team Building
- Process Improvement
- Operational Excellence
- Leadership
- Manufacturing
- Iso
- Business Process Improvement
- Process Engineering
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