Global QA IT & Validation Director: Lead Digital Compliance

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

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.