Senior Clinical Quality Auditor performing internal audits, analyzing results, and collaborating with clinical operations teams at DaVita. Assisting leadership with daily operations of the Clinical Quality Auditing team.
About the role
- GVP Auditors supporting compliance reviews across GCP clinical sites and vendors in Japan. Prepare detailed reports and collaborate with clients to ensure quality standards.
Responsibilities
- Conduct Good Pharmacovigilance Practice (GVP) audits (planning, agenda, physical or remote audit, and report writing)
- Evaluate investigator sites, CROs, and vendor compliance or qualification.
- Prepare comprehensive audit reports detailing findings and root-causes.
- Provide written audit reports in English.
- If required will provide corrective actions support and present findings to QA leadership and stakeholders
- Work collaboratively with clients to ensure quality standards.
Requirements
- Minimum 10+ years of Clinical Quality Assurance and/or Pharmacovigilance Practice (GVP) experience.
- Minimum 5+ years of Pharmacovigilance Practice (GVP) auditing experience.
- Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness activities.
- Demonstrated experience in developing and implementing quality assurance plans, audit programs, and corrective action plans.
- B2 level in English communication, verbal and written
- B2 level in Japanese communication, verbal and written
- Bachelor's degree
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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