Director QA IT & Validation

IBSA Nordic; Tveje Merløse; On-site; DKK 1,300,000 - 2,100,000; Full time

Job summary

Pharmacosmos A/S, a global leader in carbohydrate chemistry and iron deficiency therapies, seeks a Director QA IT & Validation to lead QA IT across the organization and drive strategic quality oversight of GxP IT systems. Reporting to the EVP Global Quality, you will steer validation projects, data integrity initiatives and major digital transformations including Veeva and ERP deployments.

You bring deep QA IT experience in regulated environments, strong leadership, and a proactive ability to

Qualifications

• Extensive experience in QA IT and computerized system validation within a regulated pharmaceutical or life sciences environment.
• In-depth knowledge of EU GMP and FDA requirements governing GxP‑relevant IT systems.
• Proven leadership and management capabilities with a strategic mindset and ability to translate regulatory requirements into practical business solutions.

Responsibilities

• Lead QA IT & Validation across a global organization and manage a small specialist team.
• Define and drive the QA IT strategy and ensure compliance across the system lifecycle.
• Oversee supplier audits, IT vendor qualifications and IT governance in collaboration with cross-functional partners.

Skills

Leadership

QA IT

GxP Compliance

Regulatory Knowledge

Digital Transformation

Veeva

ERP

Stakeholder Management

Tools

eQMS

Veeva Vault

ERP systems

Job description

About the job Director QA IT & Validation

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 organisational 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 organisations 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.