Director QA IT & Validation

Venaris Executive Search; Holbæk; On-site; DKK 1,800,000 - 2,400,000; Full time

Job summary

Pharmacosmos A/S seeks a Director of QA IT & Validation to combine strategic leadership with hands-on quality oversight in a regulated pharma environment. You will lead three specialists, own the eQMS, and drive IT quality governance across global IT systems, supporting digital transformations such as Veeva and ERP implementations.

You will partner with IT, Regulatory Affairs, and Production, ensuring EU GMP and FDA compliance, data integrity, and effective supplier audits in a highly dynamic

Qualifications

• Extensive experience in Quality Assurance and computerized system compliance in a regulated pharmaceutical or life sciences environment.
• In-depth knowledge of computerized system validation and EU GMP / FDA requirements.
• Proven leadership/management capabilities with a strategic mindset and ability to translate regulatory requirements into practical solutions.

Responsibilities

• Lead QA IT & Validation across the organization and oversee quality oversight of GxP-regulated IT systems.
• Provide strategic leadership on IT quality, computerized system validation, data integrity, and quality governance; collaborate with IT, Regulatory Affairs, Production, QC and external vendors.
• Act as System Owner for the eQMS, oversee supplier audits and IT vendor qualifications, and drive continuous improvement initiatives.
• Represent Quality in IT governance forums and support major digital transformation initiatives, including ERP and Veeva implementations.

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.

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

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.