Head of IT Compliance & Service Excellence

PolyPeptide Sweden; Malmö kommun; Sur place; SEK 1 100 000 - 1 700 000; Plein temps

Avantages offerts par ce poste

Reduced working hours

Bridge days time off

Health and wellness program

Résumé du poste

PolyPeptide Sweden is seeking a Head of IT Compliance & Service Excellence to lead a global team of seven specialists based in Sweden and India, with a base in Malmö. The role focuses on IT compliance, GxP governance, and validation while delivering practical guidance and strategic priorities.

You will collaborate with Quality Assurance, cybersecurity, validation and site leadership to modernize governance and validation in a cloud-based environment, ensuring regulatory rigor and impactful

Qualifications

• Proven people-management experience leading international specialist teams.
• Several years of IT compliance, validated systems, IT governance, audit support or related leadership.
• Strong knowledge of GxP, GAMP 5, validation, inspection readiness and quality documentation.

Responsabilités

• Lead, coach and develop the global IT Compliance & Service Excellence team across locations.
• Set direction and translate objectives into priorities, plans and accountabilities.
• Strengthen risk-based IT compliance, GxP governance and computerized system validation.
• Lead audits, inspections, customer reviews and certification activities with structured follow-up.
• Be a key contact for Quality Assurance and stakeholders on compliance and inspection readiness.
• Advance ITIL-based service management with clear process ownership and metrics.
• Drive standardization and simplification of governance and service processes.

Connaissances

People management

IT compliance

GxP governance

IT governance

Audit experience

Service management

Communication skills

Formation

Bachelor's degree or equivalent practical experience

Outils

ITIL

Description du poste

About us

PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical through to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide’s shares (SIX: PPGN) are listed on SIX Swiss Exchange.

United by Purpose

At PolyPeptide, we take pride in contributing to medicines that make a real difference to people's lives and health. Here, you will become part of work that truly matters, every single day. We are driven by our core values: trust, innovation and excellence. This is reflected in how we collaborate, solve problems, and uphold our responsibility for quality and safety for the patients ultimately affected by our work.

We are a company undergoing rapid development. Our growth brings a fast-paced environment, change and new opportunities for both employees and the business. Here, you will grow together with us. If you are looking for a workplace where purpose, community and development go hand in hand, then PolyPeptide is the right place for you.

The opportunity

As Head of IT Compliance & Service Excellence, you will lead a global team of seven experienced specialists based in Sweden and India. Your focus will be to provide clear direction, build capability and create conditions for the team to deliver with confidence across IT compliance, GxP governance, computerized system validation and service excellence.

As a member of the Global IS/IT management team, you will translate strategic objectives into clear priorities and ensure that compliance and service-management practices are practical, proportionate and embedded in daily operations. You will work closely with leaders and specialists across Global IS/IT, Quality Assurance, validation, site functions, Information & Cybersecurity, project teams, suppliers, system owners and the wider business.

The function operates across the full IT landscape, covering both applications and infrastructure, and plays a central role in audits, inspections, customer reviews, certifications and risk management. With a mature compliance foundation and a digital validation platform already in place, the next step is to modernize governance and validation for an increasingly cloud-based and continuously evolving technology environment—without compromising regulatory rigor.

This is first and foremost a people-leadership role. You do not need to be the leading technical expert in every discipline, but you should have the knowledge and judgement to guide experienced specialists, challenge constructively and make sound decisions in a regulated environment. By setting expectations, removing obstacles and building strong collaboration across locations and functions, you will help shape the continued development of IT compliance and service excellence at PolyPeptide. Based in Malmö, the role offers significant visibility and includes representing the function in customer meetings, audits, inspections and senior management forums.

Your key responsibilities

• Lead, coach and develop the global IT Compliance & Service Excellence team, building engagement and effective collaboration across locations and cultures.
• Set the function’s direction and translate Global IS/IT objectives into clear priorities, plans and accountabilities.
• Strengthen risk-based IT compliance, GxP governance and computerized system validation throughout the system lifecycle.
• Lead support for audits, inspections, customer reviews and certification activities, ensuring structured follow-up of risks, observations, CAPAs, deviations and improvement actions.
• Act as a key management contact for Quality Assurance and other stakeholders on compliance and inspection readiness.
• Advance ITIL-based service management through clear process ownership, effective documentation, relevant metrics and continuous improvement.
• Drive the standardization and simplification of governance and service processes, including ownership of the Kanban system, such as Businessmap.
• Coordinate relevant ISO/IEC 27001 activities with the Information & Cybersecurity function.
• Translate complex compliance and service matters into practical guidance, training, priorities and management information.
• Build trusted relationships and represent the function in management forums, customer meetings, audits and inspections.

What you bring

• Proven people-management experience, with the ability to engage, coach and develop international specialist teams.
• Several years of experience in IT compliance, computerized system validation, IT governance, audit support, service management or a related leadership role.
• Strong knowledge of GxP, GAMP 5, validation, inspection readiness and quality documentation in pharmaceuticals, biotech, food or another regulated industry.
• Good understanding of ITIL, ISO/IEC 27001, internal controls, service-oriented governance and risk-based ways of working.
• Experience leading audits, reviews and compliance follow-up in a structured, evidence-based and pragmatic way.
• The ability to create and maintain clear procedures, standards, governance documents, training materials, reports and audit evidence.
• Strong communication and stakeholder-management skills, including the confidence to influence senior audiences and challenge established approaches constructively.
• A proactive, accountable and mature leadership style, with the judgement to balance modernization and progress with GxP discipline.
• A relevant bachelor’s degree or equivalent practical experience. Certifications such as ITIL, CISA, ISO 27001 Lead Implementer/Lead Auditor or GAMP/CSV are an advantage.

PolyPeptide offers a dynamic work environment during an exciting growth journey, where you have the chance to both challenge yourself and make an impact. With us, you not only get the opportunity to truly make a difference, but also to be part of a great team where we have fun together. With favorable reduced working hours, time off on bridging days, and a strong focus on health and wellness activities, we create conditions for well-being both at and outside of work.

For further information about the position, please contact the hiring manager, Thomas Gerd Hansen at [e-mail] . For information from labor unions, you can contact the chairperson of Akademikerförbundet or Unionen, who can be reached at 040-36 62 00.