Business Capability Specialist
Business Capability SpecialistCambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 11216About the RoleAs 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.Your ContributionAct as a trusted partner to Medical Affairs and MSPv teams to understand their needs and identify technology solutions aligned with BioNTech's strategic goalsAnalyze current business processes, identify gaps, and propose innovative digital solutions to enhance efficiency and effectivenessLead or support the planning, prioritization, implementation, and operational management of technology projects within GxP environmentsCollaborate with cross-functional teams to develop process documentation (as-is/to-be), system requirements, functional specifications, and testing protocolsSupport technology roadmap development by working closely with Business Partners and portfolio management teamsPartner with vendors to implement new technology solutions while ensuring seamless integration into existing systemsTroubleshoot 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 ReportsCollaborate with procurement, legal, finance, quality partners, and other stakeholders on contracts and operational processes for quality systemsA Good MatchBachelor's degree in Computer Science, Mathematics, Information Systems, or Life Sciences-related fields5+ years of experience as a Business Analyst within the Life Sciences industry; experience supporting Medical Affairs or MSPv is highly preferredDeep understanding of R&D business processes and data management within pharmaceutical settingsStrong knowledge of technologies and trends in the pharmaceutical industry; experience supporting digital platforms commonly used in Global Development organizations is a plusExpertise in business process mapping efforts (as-is/to-be), gap analysis methodologies, project management principles, and leading international project teamsFamiliarity with GxP guidelines (e.g., 21 CFR Part 11) and Computer System Validation processesExceptional analytical skills combined with a proactive mindset to solve complex problems collaborativelySuperb interpersonal skills with an ability to engage effectively across diverse teamsExpected Pay Range: $113,600/year to $181,600/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).Your BenefitsBioNTech 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 InsuranceLife, AD&D, Critical Illness InsurancePre-tax HSA & FSA, DCRA Spending AccountsEmployee Assistance & Concierge Program (EAP) available 24/7Parental and Childbirth Leave & Family Planning AssistanceSitterstream: Virtual Tutoring & Childcare MembershipPaid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.401(K) Plan with Company MatchTuition Reimbursement & Student Loan Assistance ProgramsWellbeing Incentive Platforms & IncentivesProfessional Development ProgramsCommuting Allowance and subsidized parkingDiscounted Home, Auto & Pet Insurance...and more!More details to be shared.