Director, QA IT & Validation — Global GxP & Digitalization

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

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