Business Capability Specialist

Responsibilities

• Act as a trusted partner to Medical Affairs and Medical Safety & Pharmacovigilance (MSPv) teams to identify technology solutions aligned with strategic goals
• Analyze current business processes, identify gaps, and propose innovative digital solutions to enhance efficiency
• Lead the planning, prioritization, and implementation of technology projects within GxP environments
• Collaborate with cross-functional teams to develop process documentation, system requirements, and testing protocols
• Support GxP Computer System Validation (CSV) activities by creating Validation Plans, URS, Testing Protocols, and Traceability Matrices
• Partner with vendors to implement new technology solutions and ensure seamless integration into existing systems
• Troubleshoot operational issues to ensure systems meet regulatory requirements such as 21 CFR Part 11 and EMA Annex 11

Requirements

• Bachelor’s degree in Computer Science, Mathematics, Information Systems, or Life Sciences-related fields
• 5+ years of experience as a Business Analyst within the Life Sciences industry
• Deep understanding of R&D business processes and data management within pharmaceutical settings
• Expertise in business process mapping (as-is/to-be) and gap analysis methodologies
• Familiarity with GxP guidelines and Computer System Validation processes
• Strong analytical and interpersonal skills with the ability to engage effectively across diverse teams

Preferred Qualifications

• Experience specifically supporting Medical Affairs or Medical Safety & Pharmacovigilance (MSPv) teams
• Experience supporting digital platforms commonly used in Global Development organizations

Benefits

• Medical, Dental, and Vision Insurance
• 401(K) Plan with Company Match
• Paid Time Off including Vacation, Sick, and Year-End U.S. Shutdown
• Parental and Childbirth Leave & Family Planning Assistance
• Tuition Reimbursement & Student Loan Assistance Programs
• Professional Development Programs

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We are a community of innovators and scientists working to address diseases with high medical needs, such as cancer and infectious diseases, through a mission-driven approach to global health.