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.
This involves scheduling audits, selecting resources, reviewing reports, etc.
Execution of the audit (remote or on site) as the lead auditor when the audit is not contracted.
Ensure audit documentation and audit quality management system is completed according to procedures and established timelines.
Act as a liaison to internal BioNTech stakeholders through all phases of the audit.
Ensure that newly identified risks are considered for the audit strategy.
Support development of a robust CAPA (Corrective and Preventative Action) Plan and approve the CAPA plan.
Track CAPA and effectiveness checks to completion.

10 years experience in clinical trials, with at least: 6 years of experience in clinical auditing in Asia Pacific region.
3 years of experience managing people and/or projects.
Deep knowledge of quality audit methodology, with ability to execute and/or oversee clinical audits of investigator sites and/or vendor.
Applied knowledge of global and local GCP regulations
Very good understanding of Clinical Development activities, with oncology experience preferred
Excellent English skills, both written and verbal, in addition to Mandarin
Willingness to travel (at least 10% of the time)
Computer literate and proficient in Microsoft Office software, Veeva, and SharePoint.

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base.
We offer competitive remuneration packages determined by the specific role, location of employment and the selected candidate’s qualifications and experience.
The availability, eligibility, and design of the listed benefits may vary depending on location.
The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

Associate Director – Audit & Inspection Management

Key skills