Head of IT Compliance & Service Excellence

About the role

PolyPeptide, a global CDMO for peptide- and oligonucleotide-based active pharmaceutical ingredients, is looking for a Head of IT Compliance & Service Excellence based in Malmö. You will lead a global team of seven experienced specialists from Sweden and India, providing direction and building capability in IT compliance, GxP governance, computerized system validation and service excellence. The role sits within the Global IS/IT management team and covers both applications and infrastructure, with a focus on modernizing governance and validation for a cloud-based environment.

Key responsibilities

• Lead, coach and develop the global team, building engagement and collaboration across locations and cultures.
• Set the function's direction and turn Global IS/IT objectives into priorities, plans and accountabilities.
• Strengthen risk-based IT compliance, GxP governance and computerized system validation across the system lifecycle.
• Support audits, inspections, customer reviews and certification, with follow-up on risks, observations, CAPAs, deviations and improvements.
• Act as a key contact for Quality Assurance and other stakeholders on compliance and inspection readiness.
• Advance ITIL-based service management through process ownership, documentation, metrics and continuous improvement.
• Drive standardization of governance and service processes, including ownership of the Kanban system (Businessmap).
• Coordinate ISO/IEC 27001 activities with the Information & Cybersecurity function.
• Represent the function in management forums, customer meetings, audits and inspections.

Required profile

• Proven people-management experience with international specialist teams.
• Several years of experience in IT compliance, computerized system validation, IT governance, audit support, service management or a related leadership role.
• Bachelor's degree or equivalent practical experience.
• Strong communication and stakeholder-management skills, able to influence senior audiences.

Required skills

• Knowledge of GxP, GAMP 5, validation, inspection readiness and quality documentation.
• Understanding of ITIL, ISO/IEC 27001, internal controls and risk-based ways of working.
• Experience leading audits, reviews and compliance follow-up.
• Certifications such as ITIL, CISA, ISO 27001 Lead Implementer/Lead Auditor or GAMP/CSV are an advantage.

What we offer

• Favorable reduced working hours and time off on bridging days.
• A strong focus on health and wellness activities.