Description
Summary A Quality Assurance leader with 25+ years of cGXP expertise working in the Biotech and Commercial Pharma manufacturing industry. Extensive experience working directly with USA and EU CMOs/CTLs dealing with process drug development/ process troubleshooting, process validation, inspection readiness, and IMP distribution/ disposition. Successful FDA/EMA/ROW inspections and approval history with expertise leading global PAI Readiness programs to commercialization. Solid background in commercial aseptic manufacturing/ filling operation experience. A Quality Champion who advocates continuous Quality improvement and cGXP leadership.
Work Experience
| COMPANY | POSITION HELD | DATES WORKED |
|---|---|---|
| (Confidential) | Senior Qa Consultant | 3/2017 - Present |
| Ansun Biopharma Inc. | Senior Director Of Quality | 9/2014 - 3/2017 |
Accomplishments
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