Data Integrity Lead

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.

 

 

Data Integrity Lead 

 

Primary responsibilities include:

• Responsible for executing, improving and maintaining all document control processes, data integrity related business processes and QS GxP computerized systems supporting the GMP functions at the site. This includes document release, controlled copy and label issuance, document and records management.
• Provide mentorship and advice on approved procedures, standardization and requirements associated with the quality management system (QMS) and data integrity including ALCOA+.
• Lead Quality Systems staff including recruitment, performance management, hiring along with staff training and development.
• Analyze metrics to measure the effectiveness of the quality system.
• Support Quality Management Review.
• Subject Matter Expert and Key User supporting Documentation and Quality Event users in the eQMS.
• Identify and raise compliance gaps across the quality system.
• Execute critical initiatives to improve the quality system.
• Develop and deliver training to new staff on data integrity and other processes and procedures.
• Support audits (internal, regulatory)
• Support inspection readiness activities
• Promote a culture of quality and drive enthusiasm for data integrity compliance.
• Actively collaborate and present solutions
• Execute critical initiatives to improve the quality system and data integrity.
• Perform other duties as required.

Requirements:

Masters’ degree with a minimum of 4+ years of combined technical experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR bachelor’s degree with 6+ years of aforementioned experience.

• Experience with Quality systems and demonstrated working knowledge in areas such as data integrity/document management, records management (e.g. archive), document change control, audits, batch record and label issuance/reconciliation, change control, deviation, CAPA, Management Review.
• Experience with cGMPs and Quality System regulatory requirements.
• Experience with Quality computerized system applications (e.g., Veeva, FileTrail)

Preferred Qualifications:

Excellent organizational skills and ability to review processes or procedures. Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (e.g., Veeva Quality Suite).

Works on multiple assignments in collaboration with various department system owners.

Excellent interpersonal, verbal and written (including editing) communication skills are crucial in this collaborative work environment.

Ability to communicate and work independently with scientific/technical personnel.

Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

 

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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.