Associate Director Audit Management

Open for hire at one of the following locations

• Cambridge Erie Street, London, Mainz Goldgrube.

• Job ID: 7525

Join our team of pioneers!

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.

Associate Director Audit Management

As Associate Director, 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.

Responsibilities:

• Core Responsibilities:

• 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.

• Additional responsibilities may include:

• Management of direct reports and/or relationships with audit vendors.

• Responsibility for audits within a particular therapeutic area, type (i.e. vendor or clinical site), and/or expertise (i.e. GxP area, digital, etc.)

• Monitoring and analyze trends in audit observations.

• Execution of the audit (remote or on site) when the audit is not contracted.

• Coordination/management/support of health authority inspections.

• Lead audit management continuous improvement efforts.

• Travel up to 10%

• Act as a technical resource/expert for a particular GxP topic.

• More than one area of technical expertise.

• Monitor and analyze trends in audit observations

What you have to offer:

• Academic degree in Life Science (advanced degree preferred)

• Masters degree desired

• 3 years experience managing people and/or projects.

• Comprehensive audit skills within a GxP discipline

• 6 years experience in clinical/PV auditing and/or years of work experience in a clinical research and/or related QA environment preferred

• Deep knowledge of quality audit methodology

• Very Good understanding of Clinical Development activities

• Excellent English skills, both written and verbal

• Willingness to travel (at least 10% of the time)

• Computer literate and proficient in Microsoft Office software

Benefits for you

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.

Have we kindled your pioneering spirit?

This vacancy is to be hired at one of the following locations

• Cambridge Erie Street, London, Mainz Goldgrube. Apply now for your preferred job and location through our careers site.

• BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important - it's a match!