James Staszewski
- Role
- Director, Global Gmp Gdp Compliance at United Therapeutics Corporation
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About James Staszewski
More than 20 years of experience in the Pharmaceutical/Medical Device Industry.…
Experience
Director, Global Gmp Gdp Compliance
United Therapeutics Corporation
Mar 2021 — Present
Manage compliance oversight of all GMP/GDP vendors Direct the activities and manage team of compliance auditors in NC and MD Key contributor to team responsible for developing first risk-based auditing program and risk analysis techniques used for GMP, GLP, GCP, GVP and GDP audits. Responsible for all external and internal GMP/GDP audit activities at UT. Manage the global Quality System which includes creation of the Supplier Management program and revision of the internal auditing program. Negotiate Quality Agreements with GMP/GDP suppliers and service providers as required.
Skills
- Validation
- Technology Transfer
- CRO
- Pharmaceutical Industry
- Biotechnology
- Regulatory Submissions
- Process Simulation
- Fda
- Quality Assurance
- Clinical Trials
- Gmp
- Clinical Development
- Quality System
- Capa
- Regulatory Affairs
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