Roan Martin
Dynamic VP Head of Quality | Experienced QA Strategist | Regulatory Standards Compliance | Cross-functional Collaboration | Leadership & Team Development | Risk Assessment | Inspection Readiness | Driving Quality Culture
- Role
- Vice President, Quality at Apnimed
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Roan Martin
Dynamic pharmaceutical industry leader deeply experienced in quality compliance and…
Experience
Vice President, Quality
Jun 2025 — Present · Cambridge, MA, US
Responsible for oversight of product and clinical trial compliance by managing and improving existing quality systems and ensuring appropriate controls. This includes overseeing the expansion and implementation of a fit for purpose Quality Management System (QMS), development of documents, training of staff, and quality oversight of contract service providers.Responsible for managing the Pre-Approval and Bioresearch Monitoring Program inspection readiness efforts.
Education
University of the Free State
BSc
Anglia Polytechnic University, Cambridge (UK)
Diploma of Credit in Research Quality Assurance
University of the Free State
BMedSc Hons
University of the Free State
MBChB
Skills
- Gxp
- Clinical Trials
- Quality System
- Ich-Gcp
- Sop Development
- Clinical Research
- Management
- Regulatory Submissions
- Quality Assurance
- 21 Cfr Part 11
- Quality Management
- Edc
- Clinical Data Management
- Ctms
- Glp
- Regulatory Affairs
- Auditing
- Protocol
- CRO
- Pharmaceutical Industry
- Sop
- Fda
- Pharmacovigilance
- Gcp
- Clinical Development
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