Technology Compliance Specialist

About the role

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

Key responsibilities

• Maintain compliance with global SDLC/CSV, data integrity, and IT security policies, including change control, periodic reviews, access management, disaster recovery, and incident investigations.
• Support regulatory audits and inspections as the primary liaison, managing documentation, auditor requests, and inspection tracking.
• Act as Subject Matter Expert for DMO‑owned compliance and validation processes, providing guidance on validation strategy, system compliance, and risk management.
• Ensure continuous inspection readiness through mock audits, compliance assessments, and proactive remediation of gaps.

Required profile

• Degree in Science, Engineering, IT or related field with at least 3 years of CSV experience in a GxP‑regulated environment.
• Strong knowledge of CSV, data integrity, SDLC, and regulatory requirements such as EU Annex 11, 21 CFR Part 11, GMP Data Integrity Guidance, and SOX.
• Proven ability to collaborate across technical, quality, and business functions and communicate effectively with stakeholders.

Required skills

• Computer Systems Validation (CSV)
• Data Integrity
• Software Development Life Cycle (SDLC)
• IT Security and cybersecurity controls
• EU Annex 11 and 21 CFR Part 11 compliance
• GMP Data Integrity Guidance
• Sarbanes‑Oxley (SOX) IT compliance
• Automation, instrumentation & control systems
• IT compliance management
• Project management principles