James Carroll
- Role
- Head of Gra Compliance, Qms at Takeda
- Location
- Wilmington, NC, US
- LinkedIn followers
- 500 followers
About James Carroll
I am known for taking things from good to great. I excel at evaluating functions…
Experience
Head of Gra Compliance, Qms
Jan 2020 — Present
Lead a team with global responsibility that ensures sustained and continuously improved compliance with the Takeda Global Regulatory Affairs QMS in alignment with Takeda Global Quality, and Takeda R&D Quality. I drive system efficiencies, provide oversight, guidance and leadership, ensuring internal staff, external partners, and local operating companies are compliant with global regulatory requirements and expectations.
Education
University of Mount Olive
BS, Business Management and Organizational Development
Skills
- Gxp
- Isotrain
- Computer System Validation
- Standard Operating Procedure (Sop)
- R&D
- Life Sciences
- Gmp
- Capa
- Clinical Trials
- Gcp
- Clinical Development
- Lifesciences
- Sop
- Training
- Technology Transfer
- Sharepoint
- Fda
- Quality System
- Learning Management Systems
- Quality Assurance
- Business Alignment
- 21 Cfr Part 11
- Glp
- Microsoft Office
- Lims
- U.s. Food and Drug Administration (Fda)
- Ctms
- Quality Auditing
- Vaccines
- Process Improvement
- Corrective and Preventive Action (Capa)
- Leadership Development
- Regulatory Affairs
- Curriculum Development
- Good Laboratory Practice (Glp)
- Regulatory Submissions
- Drug Development
- U.s. Title 21 Cfr Part 11 Regulation
- Strategy
- Pharmaceutical Industry
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