Candance Gingles
- Role
- Director Quality Systems and Engineering at 辉瑞
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Candance Gingles
I’m an operations and quality leader with a track record of leading complex manufacturing…
Experience
Director Quality Systems and Engineering
Nov 2020 — Present
Responsible to the Site Quality Operations leader. Direct Documentation and Change Management, Regulatory Compliance, Complaint reporting, Training, Quality Engineering, and Programs functions. Manage up to 110 quality professionals. • Restructure organization combining Quality Engineering and Quality Systems teams. • Site’s Data Integrity Lead, responsible for implementing site’s Data Integrity Program. • Team facilitates over 20 external audits annually. • A diversity, equity and inclusion champion.
Education
North Carolina State University
Bachelor of Science, Industrial Engineering
1982 — 1987
Skills
- 21 Cfr Part 11
- Standard Operating Procedure (Sop)
- Process Improvement
- Iso 13485
- Aseptic Processing
- Industrial Engineering
- Strategy Development
- Strategy
- Lean Manufacturing
- Six Sigma
- Fda
- Fda Gmp
- Project Management
- Gmp
- Employee Training
- Costing
- Plant Management
- U.s. Food and Drug Administration (Fda)
- Gxp
- Validation
- V&V
- Process Engineering
- Quality Assurance
- Pharmaceutical Industry
- Root Cause Analysis
- Change Control
- Change Management
- Cgmp
- Change Leadership
- Manufacturing
- Operational Excellence
- Training & Development
- Medical Devices
- Sop
- Cross-Functional Team Leadership
- Target Costing
- Quality System
- Continuous Improvement
- Capa
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