QA Compliance Manager - Clinical Trials
Thermo Fisher Scientific · Taipei City, Taiwan
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Thermo Fisher Scientific seeks a Compliance Manager to oversee GxP audits and regulatory inspections across clinical trial operations, primarily in the APAC region. The role involves managing audit readiness, inspection support, compliance documentation, and leading quality improvement initiatives for internal teams and client sites.
What they're looking for
- Bachelor's degree in biology, pharmacy, or related field
- 5+ years quality assurance experience in clinical research or GxP environments
- GCP certification and knowledge of regional clinical research regulations
- 1+ years management or leadership experience
- Expertise in audit conduct, inspection hosting, and root cause analysis
- Advanced Microsoft Office proficiency; Veeva QMS experience preferred
- Strong written and verbal communication with medical/scientific terminology
What you'll be doing
- Provide GxP audit and inspection readiness consultation to project teams and clients
- Lead and review internal and external audits and regulatory authority inspections
- Support root cause investigation and CAPA development for audit findings
- Develop compliance tracking tools, guidance documents, and quality management procedures
- Mentor staff and lead process improvement initiatives across clinical operations
Privacy & handoff
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