Global IT Compliance & Quality Advisor

Novo Nordisk A/S

Ballerup

On-site

DKK 743,000 - 1,092,000

Full time

14 days+

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Job summary

Novo Nordisk A/S in Ballerup invites an IT Compliance Advisor (Specialist) to shape compliance across global IT infrastructure. You will guide teams on regulatory matters, drive audit readiness, and support continuous improvement of IT services.

You will work with IT Service Managers and Solution Owners across Denmark and beyond. We seek a seasoned professional with strong regulatory expertise (GAMP 5, GxP, 21 CFR Part 11, EU Annex 11), ITSM experience (ServiceNow) and excellent communication,

Qualifications

Minimum 5 years' experience with qualification or validation in a regulated environment, with at least 3 years in IT.
Expertise in regulatory requirements such as GAMP 5, GxP, 21 CFR Part 11 and EU Annex 11.

Responsibilities

Acting as Quality Compliance Advisor and QMS expert for assigned areas, guiding Service Managers, IT Architects, Technical SMEs and IT Solution Owners through implementation, testing and retirement processes.
Owning and driving cross-domain qualifications, authoring central SOPs and serving as content owner for critical IT documentation.
Serving as SME on deviations and driving audit readiness preparation, tracking, monitoring and closure of audit actions.
Advising on the quality of documentation including supplier assessments, GxP Change Requests, requirement specifications, test plans, test reports and risk assessments, mainly handled in ServiceNow.
Driving larger compliance activities including upskilling of quality compliance competencies across the IT infrastructure area.
Analysing and driving automation activities within compliance, including AI implementation.
Helping to implement and execute the Enterprise IT & Quality strategy of Quality leadership.