IT Compliance and Validation Lead

Quick Facts

• Role: IT Compliance and Validation Lead

Description

Lead computer systems validation (CSV) for IT infrastructure, IT systems, and computerized equipment supporting laboratories, manufacturing, utilities, facilities, and warehousing. Ensure IT solutions are validated, compliant, and ready for inspection, while guiding project teams and improving the CSV approach. Align validation and documentation with applicable regulatory expectations and internal IT QMS requirements.

Responsibilities

• Lead CSV validation activities for IT infrastructure, IT systems, and computerized equipment across relevant business and lab/manufacturing areas

• Ensure compliance with regulations and standards including 21 CFR Part 11, EU Annex 11, GAMP, and NIS2

• Facilitate, review, approve, and develop validation deliverables (URS, DQ, FMEA, risk assessments, FAT, SAT, IQ/OQ/PQ protocols, operating and maintenance instructions)

• Perform risk assessments and impact analyses and define mitigation approaches

• Guide and support project teams on validation and qualification requirements

• Improve CSV documentation and processes; apply lessons learned and track regulatory changes

• Ensure compliance with Novo IT QMS requirements and harmonize local IT QMS with Novo standards

• Lead and develop the direct report; potential to grow the team over time

Requirements

• Bachelor’s degree in Information Technology or a related field

• 5+ years of IT compliance experience (pharmaceutical API and/or finished-product manufacturing preferred)

• 3+ years of experience in validation and testing of IT solutions

• Subject matter expert experience for audits and inspections

• Experience with GxP, change management, and deviation handling

• Experience with incident, problem, and change management in IT

• Strong communication skills in Czech and English

Benefits

• Salary range: 1,188,980 to 2,080,720 CZK (annual base salary)

• Possible short-term and/or long-term incentives and other employee benefits based on level, location, and benchmarks