IS/IT Qualification And Compliance Specialist

PolyPeptide is on a transformative growth journey – expanding globally, investing in new technologies, and strengthening our governance, risk, and compliance capabilities across the organization.

We are looking for an IT Compliance Specialist to be part of our growing team to support and enhance our global IT compliance framework. This is an important role where you will combine 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, reporting on daily operations to our IT Compliance Manager, working closely with QA, risk owners, and stakeholders across multiple sites and time zones. We aim for compliance through excellence to ensure that our IT systems, policies, and processes meet the highest standards while enabling the business to move forward.

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 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. PolyPeptides shares (SIX: PPGN) are listed on SIX Swiss Exchange.

Our Values

• Trust – 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 Role

In this role, you will support and develop our Governance, Risk, and Compliance procedures, ensuring documented evidence of compliance with ISO27001, NIS2, and relevant GMP requirements. You will balance administrative tasks with a forward-looking, improvement-driven mindset – helping the organization evolve while staying inspection-ready.

You will:

• Support IT Service Owners in creating documents for qualification of IT Infrastructure and Services.
• Perform System Impact Assessments and facilitate the supplier qualification process with relevant stakeholders from IT and Line of business.
• Perform periodic review on IT infrastructure and applications in coordination with Service Owners and Solution Managers
• Support Solution Managers in performing user baselines and audit trail reviews.
• Monitor and support risk management activities, maintaining the IT risk register and collaborating with risk owners on mitigation plans.
• Participate in ISO27001:2022 certification activities, including control monitoring, reviews, and documentation.
• Being able to support the IS/IT Asset and License Specialist during high peak periods, vacation or other absence.
• Maintain Global SOPs and templates in line with applicable regulations (21 CFR Part 11, Annex 11) and GAMP 5.
• Support in audits and manage internal and external auditor requirements and compliance adherence.
• Participate in global IT compliance meetings, supporting stakeholders across geographies.
• Develop and deliver training on compliance, GMP, and supplier qualification processes for IS/IT personnel and consultants.
• Participate in computerized system validation tasks, including change requests and periodic reviews.

We 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 participate within IT compliance in a growing, international CDMO, where you will work at the intersection of IT, risk and quality. 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.