Associate Director Audit & Inspection Management

Bion Environmental Technologies Inc

Shanghai, China
On-site
Clinical investigator site audits
Clinical vendor audits
Apac region audits
Responsible for audits within the APAC region, ensuring audit objectives and scopes are risk-based in alignment with the audit strategy

Job Summary

  • Responsible for audits within the APAC region, ensuring audit objectives and scopes are risk-based in alignment with the audit strategy.
  • Coordinate and oversee audits performed by contracted auditors, including scheduling, resource selection, and report review.
  • BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base.

Matching Summary

Responsible for audits within the APAC region, ensuring audit objectives and scopes are risk-based in alignment with the audit strategy.

Skills & Requirements

Must-have

  • Clinical investigator site audits
  • Clinical vendor audits
  • APAC region audits
  • GCP regulations knowledge
  • CAPA plan development and approval

Nice-to-have

  • Oncology experience preferred
  • Risk-based audit objectives

Key Requirements

  • 10 years experience in clinical trials
  • 6 years experience in clinical auditing in Asia Pacific
  • 3 years experience managing people/projects
  • Excellent English and Mandarin skills
  • Willingness to travel at least 10%

Work Rights

Not specified

Tailored Resume

Cover Letter