Global QA IT & Validation Director - GxP & Strategy

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

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