Senior Director, Regulated Applications & Compliance

Pharmacosmos Group; Holbæk; On-site; DKK 1,800,000 - 2,400,000; Full time

Job summary

Pharmacosmos A/S seeks a strategic Head of Regulated Applications to lead GxP application management for R&D and regulated business areas. You will drive governance, validation and lifecycle management of critical systems, including enterprise platforms like Veeva, while guiding vendors and budgets.

You will build a high-performing global IT team, align technology with regulatory requirements, and shape an ambitious digital transformation across the organization for better patient outcomes.

Qualifications

• Relevant university degree in Computer Science, Life Science, Engineering, Information Technology, Business, or related discipline.
• Proven experience leading application management in pharmaceutical/biotech/medical device industries.
• Experience with platforms such as Veeva or similar GxP regulated enterprise solutions.
• Strong understanding of application lifecycle management, IT governance, validation, compliance, vendor management, budgeting, and service delivery.

Responsibilities

• Lead Regulated Applications with end-to-end strategy, governance and lifecycle for GxP apps.
• Build and develop Regulated Applications team and foster collaboration and accountability.
• Define and execute application strategy and roadmap aligned with business priorities and regulatory requirements.
• Own the regulated application portfolio with governance, compliance, cybersecurity, risk management and inspection readiness.
• Partner with senior stakeholders across R&D, Quality, Enterprise Architecture, Cyber Security and vendors; oversee vendor management and budgets.

Education

Bachelor’s degree in Computer Science, Life Science, Engineering, Information Technology, Business, or related discipline

Tools

Veeva

Job description

Pharmacosmos A/S seeks a strategic Head of Regulated Applications to lead GxP application management for R&D and regulated business areas. You will drive governance, validation and lifecycle management of critical systems, including enterprise platforms like Veeva, while guiding vendors and budgets.

You will build a high-performing global IT team, align technology with regulatory requirements, and shape an ambitious digital transformation across the organization for better patient outcomes.