IT Compliance Specialist (Life Sciences, Greater Copenhagen)

Job summary

The IT Compliance Specialist will play a crucial role in enhancing application compliance and fostering a strong governance mindset within the organization. This position involves supporting GxP-regulated IT systems throughout their lifecycle and collaborating with various stakeholders to identify and address compliance gaps.

Qualifications

• At least 8 years of hands-on experience in GxP IT compliance within the Life Sciences, MedTech, or pharmaceutical sectors.
• Previous roles may include IT Compliance Specialist, IT QA, or CSV Specialist, with a focus on compliance frameworks and process enhancement.
• Strong knowledge of CSV and application lifecycle practices to ensure regulatory compliance while maintaining effective system operations.
• Experience in translating regulatory expectations into actionable guidance for IT and business teams.

Responsibilities

• Provide advisory support and execute hands-on tasks for GxP-regulated IT systems, including the creation of validation deliverables like validation plans and risk assessments.
• Maintain and revise CSV-related procedures to ensure they align with regulatory standards and are well understood by stakeholders.
• Collaborate with IT, QA, and business units to identify compliance gaps and initiate improvement actions.
• Contribute to quality processes by assisting with SOPs, Change Requests, Deviations, CAPAs, and other continuous improvement initiatives.
• Foster a culture of IT compliance through collaboration and knowledge sharing across functions.

Skills

• Strong consultancy mindset with the ability to translate complex business needs into actionable compliance guidance.
• Excellent communication and stakeholder management skills, capable of engaging effectively with diverse audiences.
• Pragmatic approach to balancing compliance requirements with practical business needs, providing effective and feasible solutions.

Education

• Relevant degree or equivalent experience in a related field is preferred.

Tools

• Familiarity with compliance management tools and methodologies relevant to GxP regulations.