Director QA IT & Validation

PHARMACOSMOS A/S; Holbæk; On-site; DKK 1,345,000 - 1,943,000; Full time

Job summary

Pharmacosmos A/S in Denmark seeks a Director QA IT & Validation to lead strategic quality oversight of GxP IT systems and drive major digital transformation initiatives. You will manage a small team, ensuring compliance with EU GMP and FDA requirements while partnering across IT, Regulatory Affairs, Production, and QA to embed quality throughout the system lifecycle.

This role shapes QA IT strategy, acts as System Owner for the eQMS, and supports supplier audits, IT vendor qualifications, and

Responsibilities

• Lead QA IT & Validation across a global organization.
• Ensure quality oversight of GxP-regulated IT systems.
• Provide strategic leadership on IT quality, validation, data integrity and governance.
• Collaborate with IT, Regulatory Affairs, Production and QA to embed compliance in system lifecycles.
• Oversee Veeva implementation and a new ERP platform as part of digital transformation.
• Act as System Owner for the eQMS and oversee supplier audits and IT vendor qualifications.
• Drive continuous improvement and represent Quality in IT governance forums.

Job description

As the new Director QA IT & Validation, you now have a unique opportunity to combine strategic leadership with hands-on quality oversight in an international, highly regulated environment where digitalization and business growth are high on the agenda.

Deadline
September 15, 2026

Department
Quality Assurance

Lead QA IT & Validation across a global organization
As Director QA IT & Validation, you will lead a team of three specialists and take overall responsibility for the quality oversight of GxP-regulated IT systems across the organization. Reporting to the EVP, Global Quality, you will be a key member of the Global Quality Management Team, shaping the QA IT strategy and ensuring compliance with global regulatory requirements. You will provide strategic leadership on IT quality, computerized system validation, data integrity, and quality governance while partnering closely with IT, Regulatory Affairs, Production, QC, and external vendors. You will play a pivotal role in major digital transformation initiatives, including the implementation of Veeva and a new ERP platform, ensuring quality and compliance are embedded throughout the system lifecycle. In addition, you will act as System Owner for the company's electronic Quality Management System (eQMS), oversee supplier audits and IT vendor qualifications, drive continuous improvement initiatives, and represent Quality in IT governance forums.

Experienced QA IT Professional with proven leadership experience
For this position, it is expected that you bring extensive experience within Quality Assurance and computerized system compliance in a regulated pharmaceutical or life sciences environment. You have in-depth knowledge of computerized system validation and are familiar with EU GMP, FDA requirements, and industry standards governing GxP-relevant IT systems, combined with practical experience supporting validation projects, quality management systems, and regulated IT environments. Finally, you possess a proven leadership/management capabilities coupled with a strategic mindset and the ability to translate regulatory requirements into practical business solutions.

You are a collaborative leader who communicates effectively across Quality, IT, and business functions and are comfortable advising stakeholders on complex compliance matters. You are comfortable engaging with stakeholders at all organizational levels and have demonstrated success influencing cross-functional decision-making in complex environments. Your strong analytical and problem-solving skills enable you to make sound decisions while balancing compliance, risk, and business needs. On a personal level, you are structured, quality-focused, and able to combine a pragmatic approach to problem-solving while maintaining a strategic mindset, enabling you to balance regulatory compliance with business needs in an increasingly digital environment.

Join Pharmacosmos on an ambitious international growth journey
This is your opportunity to join Pharmacosmos at a time of strong ambition and continued investment and become part of a competent Global Quality organizations that supports the business in seizing opportunities to benefit more patients globally and address unmet medical needs.

About Pharmacosmos
Pharmacosmos A/S is a global leader in carbohydrate chemistry and innovative treatments for iron deficiency and iron deficiency anaemia. Building on our foundational expertise in carbohydrate chemistry and cell cycle biology, we develop innovative treatments for unmet patient needs, with a focus on iron metabolism and blood-related disorders. Founded in 1965 and headquartered in Denmark, our team is made up of more than 650 specialists across the UK, Ireland, the Nordics, Germany, Canada, and the USA. Learn more about Pharmacosmos at www.pharmacosmos.com.