Overview
Skills
Job Details
Position Summary
The IT Manager will oversee daily IT operations for a rapidly growing, highly regulated biotechnology company. This role combines hands-on technical leadership with vendor management, budget accountability, and strict adherence to GxP and other regulatory requirements. Partnering with teams across R&D, Quality, Clinical, and Commercial, the IT Manager will ensure secure, compliant, and reliable systems that drive scientific and business success.
Key Responsibilities
IT Operations & Leadership
Lead day-to-day IT activities, guiding both internal staff and external partners.
Manage ITIL-aligned ticket queues to ensure timely resolution and exceptional service.
Maintain and govern the Configuration Management Database (CMDB) and asset inventory (hardware, software, cloud).
Vendor & Managed Services Oversight
Act as the primary liaison to the Managed Services Provider (MSP) and technology vendors.
Negotiate and enforce SLAs to ensure cost-effective, high-quality service delivery.
Translate business requirements into Statements of Work and hold vendors accountable.
Systems Administration & Infrastructure
Oversee enterprise platform administration.
Ensure secure identity and access management (SSO, MFA) and endpoint protection.
Plan and execute system upgrades, integrations, and lifecycle management in line with industry CSV (computer systems validation) standards.
Regulatory Compliance & Validation
Own GxP compliance for computerized systems, including CSV per 21 CFR Part 11 and EU Annex 11.
Maintain change control, CAPA processes, periodic reviews, and audit readiness.
Partner with Quality and Regulatory teams to meet industry and regulatory standards.
Cybersecurity & Data Privacy
Coordinate vulnerability assessments, phishing simulations, and incident-response activities with the MSP and SOC.
Align security controls with NIST CSF, ISO 27001, GDPR, and HIPAA.
Budget Management & Strategic Planning
Develop and manage IT departmental OPEX and CAPEX budgets with the COO.
Monitor expenditures, identify cost-saving opportunities, and ensure fiscal responsibility.
Maintain an 18 24 month IT roadmap aligned with milestones such as inspections, scale-up, and commercial launch.
Cross-Functional Collaboration
Act as the face of IT across the organization, translating technical needs into business impact.
Partner with R&D, Quality, Clinical, and Commercial leaders to support evolving business needs.
< data-start="2874" data-end="2903">Required Qualifications</>
Bachelor s degree in Computer Science, Information Systems, or related field.
5+ years of progressive IT experience, including at least 2 years in a GxP life sciences environment.
Proven experience managing vendors, MSPs, and technology budgets.
Strong knowledge of GxP compliance, CSV, and FDA audit processes.
Proficiency in Microsoft 365 administration, endpoint security, and basic networking.
Excellent leadership, organizational, and communication skills.