IT Compliance Manager

PolyPeptide Group

  • Malmö
  • Permanent
  • Heltid
  • 16 dagar sedan
PolyPeptide is on a transformative growth journey – expanding globally, investing in new technologies, and strengthening our governance, risk, and compliance capabilities across the organisation.As our current IT Compliance Manager has been appointed a new position, we are looking for an IT Compliance Manager to lead and develop our global IT compliance framework. This is a pivotal role where you will combine deep knowledge of compliance and regulatory requirements (GAMP 5, ISO27001, NIS2, GMP) with the ability to challenge, improve, and innovate processes to support a modern, agile, and inspection-ready Global IT function.You will be part of our Cybersecurity and Service Excellence team within Global IS/IT, working closely with QA, risk owners, and stakeholders across multiple sites and time zones to ensure that our IT systems, policies, and processes meet the highest standards while enabling the business to move forward.About usPolyPeptide 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 our customers mainly in pharma and biotech, we contribute 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. Our 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.Our ValuesTrust: We build and maintain trust in all our relationships – both with each other and with our customers.
Innovation: We are curious and driven by finding smart solutions to the challenges we face.
Excellence: We always strive to deliver high quality and adapt to meet the needs of our customers.About the RoleIn this role, you will manage and develop our Governance, Risk, and Compliance framework, ensuring alignment with GAMP 5, ISO27001, NIS2, and relevant GMP requirements. You will balance regulatory compliance with a forward-looking, improvement-driven mindset – helping the organization evolve while staying inspection-ready.You will:
  • Maintain and improve Global SOPs and templates in line with GAMP 5 and applicable regulations (21 CFR Part 11, Annex 11).
  • Lead ISO27001:2022 certification activities, including planning, control monitoring, reviews, and documentation.
  • Drive risk management activities, maintaining the IT risk register and collaborating with risk owners on mitigation plans.
  • Monitor and support the implementation of new regulations (e.g. NIS2) relevant to Global ISIT.
  • Lead global IT compliance meetings, aligning with stakeholders across geographies.
  • Partner with QA for audits, inspections, and quality-related activities.
  • Develop and deliver training on compliance, GMP, and supplier qualification processes for IS/IT personnel and consultants.
  • Train the organization in and supervise the supplier qualifications process.
  • Introduce and train Global IT personnel in GMP-related activities and GSOPs.
Your ProfileWe are looking for a structured and proactive compliance professional who thrives in a regulated environment but also enjoys challenging the status quo to improve and innovate. You combine a detail-oriented and quality-conscious mindset with the drive to implement change and the confidence to advise senior stakeholders.You bring:
  • A degree in Computer Science or a related field, or equivalent hands-on experience.
  • 2–3+ years of experience in a GMP or similarly regulated industry.
  • 2–3+ years of ISO27001:2022 experience (lead implementer/auditor certification is an advantage).
  • Strong knowledge of GAMP 5, NIS2, and information security standards.
  • Excellent communication skills in English and the ability to work with stakeholders across time zones.
Why join us?This is a unique opportunity to take ownership of IT compliance in a growing, international CDMO, where you will work at the intersection of IT, quality, and regulatory affairs. You will be part of a collaborative team with the mandate to strengthen and modernize compliance practices – directly contributing to the delivery of life-changing therapies to patients worldwide.Interested? Apply now!
The position will remain open until the 14th of September 2025, but we review applications on an ongoing basis. The role is based in Malmö, Sweden.For more information, please contact line.kejsernielsen@polypeptide.com. You are welcome to contact the local union chairman for Akademikerföreningen or Unionen at +46 040-36 62 00 for support.PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a focused 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 offers products and services from pre-clinical through to commercial stages, including generics. Its active custom projects pipeline reflects the opportunities from novel drug therapies in development to fight both widespread and rare diseases. Dating back to 1952, PolyPeptide today runs a global network of six cGMP-certified facilities in Europe, the U.S. and India. PolyPeptide Group AG’s shares (SIX: PPGN) are listed on SIX Swiss Exchange.

PolyPeptide Group