Associate Director Audit & Inspection Management

Shanghai, China   |   full time   |   Job ID: 9665 

As Associate Director, Audit & Inspection Management, you are part of the Global Development Quality Assurance team. will be focused on executing and overseeing clinical investigator sites and clinical vendor audits in China and neighboring countries, in accordance with global processes.  

Your main responsibilities are:

• 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.

What you have to offer:

• 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

Your Benefits:

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 which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.