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Location

Frankfurt am Main | Germany

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Job description

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

(Senior) Manager* Audit Management

As (Senior) Manager, Audit Management you are part of the Global Development Quality Assurance team. The Audit Management group conducts Good Clinical Practice (GCP), Good Laboratory Practices (GLP), Good Pharmacovigilance Practice (GVP) and Information Technology (IT) audits and qualifications. The types of global audits include but are not limited to clinical investigator site audits, vendor audits, process/system audits, and partner audits for phase I-IV clinical trials.

Aufgaben:
Serve as the BioNtech audit lead which involves:

• Ensuring audit objectives and scope 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.
• Ensure audit documentation 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.
• Act as a technical resource/expert for a particular GxP topic.
• Support trending of audit observations.
• Execution of the audit (remote or on site) when the audit is not contracted.
• Coordinate/manage/support health authority inspections.
• Lead audit management continuous improvement efforts.
• Travel up to 10%

Qualifikationsprofil:

• Excellent English skills (written and verbal) to interact with auditees and stakeholders.
• Comprehensive knowledge of ICH GCP and GVP guidelines and other international GxP regulations as appropriate
• Critical thinking skills and understanding of Quality by Design (QbD)
• Proven interpersonal skills including good negotiating skills.
• Very good understanding of Clinical Development activities and the applicable regulations.
• Expertise in one or more technical aspects, for example: investigator site audits, vendor audits, PV audits, lab audits, IT audits, etc.
• Experience with Veeva is an added plus

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.
Click here to find out more about what we do, the careers we offer and also the benefits we provide.
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.

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Job tags

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Salary