Director QA IT & Validation

Pharmacosmos Group; Holbæk; On-site; DKK 900,000 - 1,500,000; Full time

Job summary

Pharmacosmos A/S seeks a Director of QA IT & Validation to lead a small team in ensuring quality oversight of GxP-regulated IT systems across a global organization. The role reports to the EVP, Global Quality and shapes the IT quality strategy in a highly regulated environment.

You will drive computerized system validation, data integrity, and governance, while partnering with IT, Regulatory Affairs, Production, QC and external vendors.

Qualifications

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

Responsibilities

• Lead a team of three specialists and own QA IT oversight of GxP IT systems globally.
• Provide strategic leadership on IT quality, validation, data integrity, and governance; collaborate with IT, Regulatory, Production, QC, and external vendors.
• Serve as System Owner for the eQMS; oversee supplier audits and IT vendor qualifications; drive continuous improvement.
• Oversee major digital transformation initiatives including Veeva implementation and a new ERP platform; ensure quality across system lifecycle.

Skills

QA Leadership

GxP compliance

Systems Validation

IT Governance

Regulatory Liaison

Stakeholder management

Strategic thinking

Tools

Veeva

ERP system

eQMS

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

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 .