Manager, Supplier Qualification, Auditing

Become a member of the BioNTech Family!

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.

 

 

Manager, Supplier Qualification, Auditing 

 

Primary responsibilities include:

As Manager, GMP Audit Management you are part of the Global Supplier Quality team.  The GMP Audit Management group conducts Good Manufacturing Practice (GMP) and Information Technology (IT) audits and qualifications. The types of global audits include but are not limited to supplier audits, Contract Manufacturing, Contract Testing, and partner audits for commercial programs and phase I-IV clinical trials. 

 

• Coordinate and complete all aspects of audit lifecycle: schedule, plan, issue agendas, perform audits, issue reports, evaluate responses and closure of audits/findings/CAPAs within timelines. Ensure 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.

• Support trending of audit observations.

• Establish excellent working relationships and communicate with compliance/quality groups, vendors, business partners and other functions. Act as a liaison to internal BioNtech stakeholders through all phases of the audit.

• Maintain the Approved Supplier List (ASL) and Audit Plan and documented evidence of evaluation records.

• Support global alignment on audit and vendor qualification program.

• Collaborate globally with GxP supplier groups to standardize practices.

• Track and communicate auditing and vendor management-specific metrics to management, including but not limited to Quality Management Review.

• Gather metric information for use in continuous improvement of areas of responsibility and report to management, as needed. 

Requirements:

• Bachelor of Science degree with a minimum of 8 years in Quality Assurance in an FDA - regulated environment and familiar with Health Authority regulations and guidance. Minimum of 5 years’ experience as lead auditor.

• Knowledge of clinical and commercial GMP operations, manufacturing and testing for Cell or Gene Therapy, including Apheresis collection sites.

• Demonstrated a developed knowledge of compliance requirements, and an understanding of current global and regional trends in compliance.

• Demonstrated ability to incorporate risk management fundamentals in the establishment and adherence of audits conducted.

• Excellent English oral, written communication, organizational and interpersonal skills.

• Proven interpersonal skills including good negotiating skills.

• Self-motivated, detail-oriented, and comfortable in a fast-paced company environment with minimal direction and able to adjust workload and multi-task productively based upon changing priorities.

• Travel will be required up to 60%.

 

Preferred Requirements:

• Experience with virtual and onsite audits. ASQ-CQA or equivalent certification preferred.

• Knowledge of domestic and internal regulations, including 21 CFR, EudraLex Volume 4 and applicable annexes, USP/EP compendia, ICH and ISO standards and principles.

• Knowledge o