(Senior) Manager, Audit Management - Remote

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Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We believe in scientific rigor, innovation and passion as driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence.

With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria and tuberculosis. The first ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany. A fully integrated immunotherapy powerhouse. We remain focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to people around the world to address cancer, infectious diseases, as well as a growing list of other medical conditions. To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.
 

 

(Senior) Manager, Audit Management - Remote

 

 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 US is committed to the well being of our team members and offers a variety of benefits supporting our diverse employee base. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• Medical, Dental and Vision Insurance

• Life, AD&D, STD and LTD Insurance

• HSA & FSA Spending Accounts

• Health & Wellness, including free onsite gym access

• Adoption & Surrogacy Assistance

• Vacation and Unlimited Sick Time

• Holidays and Floating Holidays, including discretionary winter shutdown

• 401(K) Plan with Significant Company Match

• Tuition Reimbursement and Professional Development

• Commuting Assistance and subsidized parking