Technology Compliance Specialist – CSV

About the role

The Technology Compliance Specialist ensures that computerized systems, data management processes, and system development activities within the Digital/Data Management Office meet global regulatory, validation, cybersecurity, and data integrity standards. This role supports inspection readiness and the continuous supply of high‑quality pharmaceutical products.

Key responsibilities

• Maintain compliance with global SDLC/CSV, data integrity, and IT security policies, including change controls, periodic reviews, access management, disaster recovery, and incident investigations.
• Support regulatory audits and inspections as the primary liaison, managing documentation, audit tracking, and mock audits.
• Serve as Subject Matter Expert for DMO‑owned compliance processes, providing guidance on validation strategy, risk management, and system administration.

Required profile

• Degree in Science, Engineering, IT or related field.
• Minimum 3 years experience in Computer Systems Validation within a GxP‑regulated environment.
• Strong knowledge of CSV, Data Integrity, SDLC, and relevant regulations (EU Annex 11, 21 CFR Part 11, MHRA guidance, SOX).
• Proven ability to collaborate across technical, quality and business functions.

Required skills

• Computer Systems Validation (CSV)
• Data Integrity
• Systems Development Lifecycle (SDLC)
• EU Annex 11
• 21 CFR Part 11
• Audit readiness and mock audits
• Change control management
• GAMP methodology