Role Summary
Vor Biopharma is seeking a Senior Director of Information Systems / Digital Systems Lead to design and deliver the company’s digital systems strategy as we prepare for global commercialization of telitacicept. This role will lead the implementation and ongoing management of regulated and enterprise systems that support Quality, Regulatory, CMC, Medical Affairs, and Commercial teams. The role partners closely with functional leaders to ensure digital tools, data, and integrations support compliance, scalability, and efficient operations across the business, and will lead a small team of IT professionals.
Responsibilities
- Digital Systems Strategy & Delivery
- Own and execute the digital systems roadmap aligned with commercialization and growth goals
- Implement and scale SaaS platforms across Quality, Regulatory, CMC, Medical Affairs, and Commercial
- Ensure systems are well integrated, user-friendly, and compliant
- Regulated Systems & Compliance
- Manage selection, validation, and lifecycle of GxP systems (QMS, RIM, LMS, eTMF, ERP, etc.)
- Partner with QA to support 21 CFR Part 11 and GxP compliance
- Establish governance for system changes and releases
- Data, Reporting & Integrations
- Support data governance, reporting, and dashboards across functions
- Oversee integrations between enterprise systems and external partners (CROs, CMOs)
- Ensure data integrity, security, and traceability
- Medical Affairs & Commercial Enablement
- Support digital capabilities for Medical Affairs and Commercial teams (e.g., Veeva, CRM, MLR)
- Enable compliant data flows and insights to support launch readiness and field engagement
- Vendor & Program Management
- Manage vendors, contracts, and system budgets
- Track risks, timelines, and value delivery for digital initiatives
- Support audit readiness and inspection preparation
Qualifications
- Bachelor’s or Master’s degree in Information Technology, Computer Science
- 10+ years of experience leading enterprise or digital transformation in biotech/pharma, with at least 5 years in commercial-readiness environments and 5 years leading a team
- Deep understanding of regulated systems (GxP, SOX, CSV) and hands-on experience with platforms such as Veeva Vault (QMS, RIM, MedComms, CRM), SAP/Sage, Kivo, Benchling, LIMS/MES, and Tableau/Power BI
- Proven success building cross-functional digital roadmaps across Quality, Regulatory, and Commercial domains
- Strong vendor management, budget oversight, and stakeholder communication skills
- Experience preparing systems and teams for FDA, EMA, and PMDA inspections
Education
- Bachelor’s or Master’s degree in Information Technology, Computer Science
Skills
- GxP, SOX, CSV
- Veeva Vault (QMS, RIM, MedComms, CRM), SAP/Sage, Kivo, Benchling, LIMS/MES, Tableau/Power BI
- Digital roadmaps across Quality, Regulatory, and Commercial
- Vendor management, budget oversight, stakeholder communication