Global Lead for IT Compliance
1 week ago
Apply locations Hillerod time type Full time posted on Posted 3 Days Ago time left to apply End Date: January 19, 2025 (18 days left to apply) job requisition id JR3984
As the Global Lead for IT Compliance & Validation, you will help set the overall Computerized System Validation (CSV) strategy and delivery support methodology for the Global CSV team, in addition to ensuring appropriate validation. This role will also have responsibility for vendor assurance and customer/regulatory audit coordination for the IT team. In this role, you will provide guidance and mentorship to the CSV team and the broader IT organization, and ensure a collaborative dialogue with QA/ITQ to ensure common understanding of our ITQMS and lifecycle requirements.
The Global leader of IT Compliance & Validation is not directly accountable for a separate budget but will contribute to the budget process and is responsible for transparency of cost and continuous optimization in their unit. The role includes responsibility for the management and development of the direct reports – in respect to quality of deliverables and cooperation. As a Global Leader, you will be responsible for a global team of between 3-8 direct reports – potentially situated across geographic sites. The role includes taking responsibility for delivery and services with impact to business units.
You will have the opportunity to work in close relationship with other leaders across sites and IT functional towers.
Principal Accountabilities:
- Develop global validation team and supporting global processes.
- Support the organization and computerized system validation team on compliance and regulatory requirements. Mentorship of internal resources.
- Continuous improvement of CSV delivery methodologies, internal processes and collaboration with ITQ.
- Develop vendor assurance practice.
- Verify external CSV resource requirements and deliverables.
- Coordinate IT audit responses supporting customer and regulatory agency audits and inspections.
Background and Education Requirements:
- Bachelor’s degree in engineering, computer science or similar is required.
- 10+ years industry relevant experience in computer system validation.
- Must also have strong knowledge of documentation standards in particular ISO and cGMP.
- A proven understanding of GAMP.
- A high level of understanding within production and IT Projects.
- Proven team management experience. Ability to lead and develop/mentor a team.
- Excellent communication and interpersonal skills, with the ability to effectively communicate with technical and non-technical stakeholders.
Desired Experience:
- Knowledge and experience within the Pharmaceutical industry.
- Overall understanding of the IT strategy and how it supports the business strategy.
- Must be able to present topics with authority to auditors.
Has this shaken your interest? Then please apply as soon as possible and latest by the 19th of January. This is a global position and can be based at any of our locations or remotely. We have European offices located in the United Kingdom (Teesside) and Denmark (Hillerød). Benefits and compensation will be governed by the location that you are based at and considered your home site.
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