Lead Business Auditor ensuring appropriate scope, quality, and execution of audits for Horizon BCBSNJ. Develops work programs and monitors ongoing performance of deficient systems.
About the role
- Good Clinical Practice (GCP) Auditors for Japan-based projects at Advarra. Conduct compliance reviews and audits for clinical sites and vendors.
Responsibilities
- Conduct Good Clinical Practice (GCP) 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 Good Clinical Practice (GCP) experience.
- Minimum 5+ years of Good Clinical Practices 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
Benefits
- N/A
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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