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

• Significant experience with e-systems/tools (e.g. Visio, ERP, eQMS, Sharepoint, Teams and Excel, Microsoft Project, Veeva).

• Critical thinking skills and understanding of Quality by Design (QbD)

• German language skills.

Benefits for you:
 

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. 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, Critical Illness Insurance

• Pre-tax HSA & FSA, DCRA Spending Accounts

• Employee Assistance & Concierge Program (EAP) available 24/7

• Parental and Childbirth Leave & Family Planning Assistance

• Sitterstream: Virtual Tutoring & Childcare Membership

• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.

• 401(K) Plan with Company Match

• Tuition Reimbursement & Student Loan Assistance Programs

• Wellbeing Incentive Platforms & Incentives

• Professional Development Programs

• Commuting Allowance and subsidized parking

• Discounted Home, Auto & Pet Insurance

…and more! More details to be shared.

BioNTech is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. BioNTech does not tolerate discrimination against employees or applicants because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, genetic information, or any other characteristic protected under applicable federal, state, or local law.

If you are unable or limited in your ability to use or access BioNTech’s online application tools due to a disability, you can request reasonable accommodations by calling 1-857-228-6231or by e-mailing jobs@biontech.de. Thank you for your interest in BioNTech.