---

---

Location

Cambridge, MA | United States

---

Job description

(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. 

Responsibilities: 

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%

What you have to offer: 

• 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 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, Gaithersburg, 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!

---

Job tags

---

---

Salary