Business Capability Specialist
About The Position
As a Business Capability Specialist, you will serve as the critical link between our business stakeholders and the Data, Digital & Informatics (DDI) organization, ensuring that technology solutions seamlessly enable key business capabilities and support BioNTech’s mission. Working closely with Medical Affairs (MA) and Medical Safety & Pharmacovigilance (MSPv) teams, you will help identify opportunities for digital transformation, translate business needs into scalable technology solutions, and ensure compliance with regulatory standards. By combining your technical expertise with a strong understanding of business processes, you will play an integral role in driving innovation, improving operational efficiency, and delivering measurable value across the organization.
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; experience supporting Medical Affairs or MSPv is highly preferred
- Deep understanding of R&D business processes and data management within pharmaceutical settings
- Strong knowledge of technologies and trends in the pharmaceutical industry; experience supporting digital platforms commonly used in Global Development organizations is a plus
- Expertise in business process mapping efforts (as-is/to-be), gap analysis methodologies, project management principles, and leading international project teams
- Familiarity with GxP guidelines (e.g., 21 CFR Part 11) and Computer System Validation processes
- Exceptional analytical skills combined with a proactive mindset to solve complex problems collaboratively
- Superb interpersonal skills with an ability to engage effectively across diverse teams
Responsibilities
- Act as a trusted partner to Medical Affairs and MSPv teams to understand their needs and identify technology solutions aligned with BioNTech’s strategic goals
- Analyze current business processes, identify gaps, and propose innovative digital solutions to enhance efficiency and effectiveness
- Lead or support the planning, prioritization, implementation, and operational management of technology projects within GxP environments
- Collaborate with cross-functional teams to develop process documentation (as-is/to-be), system requirements, functional specifications, and testing protocols
- Support technology roadmap development by working closely with Business Partners and portfolio management teams
- Partner with vendors to implement new technology solutions while ensuring seamless integration into existing systems
- Troubleshoot operational issues and ensure systems meet regulatory and validation requirements (e.g., 21 CFR Part 11, EMA Annex 11)
- Support GxP Computer System Validation activities by creating key documentation such as Validation Plans, User Requirements Specifications (URS), Testing Protocols (IQ/OQ/PQ/UAT), Traceability Matrices, and Validation Summary Reports
- Collaborate with procurement, legal, finance, quality partners, and other stakeholders on contracts and operational processes for quality systems
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
