Jim W.
Associate Director R&D Vendor & Audit Management - R&D Quality
- Role
- Associate Director R & d Vendor & Audit Management - R & d Quality at Moderna
- Location
- Greensboro, NC, US
- LinkedIn followers
- 500 followers
About Jim W.
Experienced professional with over 20 years experience in the pharmaceutical industry. Extensive knowledge of pharmacovigilance, pre and post approval global regulations, regulatory and quality systems in the human and veterinary industry. Strong management skills and leadership of global cross-functional teams. Specialties:Pharmacovigilance, Quality Systems; Business process management; Auditing for GVP, GCP, CSV; Inspection readiness; Lean Six Sigma (Green Belt); FDA, USDA, EPA and EU regulations; E2B reporting; project management; computer systems validation; CFR 21 Part 11; cross-functional leadership; relational databases; signal detection; PVWorks; ARIS Global; TrackWise; Documentum
Experience
Associate Director R & d Vendor & Audit Management - R & d Quality
Feb 2024 — Present · Cambridge, MA, US
Education
Ferrum College
Bachelor of Science (BS), Biology/Biological Sciences, General
1993 — 1997
Skills
- Pharmacovigilance
- Pharmaceutical Industry
- Fda
- Validation
- Sop
- Computer System Validation
- Cross-Functional Team Leadership
- Data Management
- Regulatory Requirements
- Regulatory Affairs
- Team Leadership
- Clinical Research
- Gcp
- 21 Cfr Part 11
- Clinical Trials
- Management
- Pvworks
- Life Sciences
- Gmp
- Regulatory Submissions
- Project Management
- Glp
- Quality Assurance
- Electronic Common Technical Document (Ectd)
- Corrective and Preventive Action (Capa)
- Gxp
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