Compliance & Validation Specialist

PolyPeptide Group

  • Malmö
  • Permanent
  • Heltid
  • 1 dag sedan
PolyPeptide is on a transformative growth journey – expanding globally, investing in new technologies, and increasing our production capacity through major site expansions and strategic projects.As part of this journey, we are launching a global SAP S/4HANA implementation and building a new ERP function from the ground up. We’re looking for an experienced IS/IT Compliance & Validation Specialist to help ensure that our new enterprise systems – especially the ERP platform – are implemented and maintained in line with industry standards, regulatory requirements, and best practices.This is a unique opportunity to join early in the ERP journey and take a central role in securing validation of a modern, global ERP system in close collaboration with Global QA.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 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.Our ValuesTrust: We build and maintain trust in all our relationships – both with each other and with our customers. We support each other and work as a team.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 be part of our global IS/IT organization and act as a key resource in securing regulatory compliance across enterprise systems – with a primary focus on the new ERP program. You’ll be responsible for system validation (CSV), audit readiness, change control, and risk management, with a strong emphasis on maintaining compliance with GxP, 21 CFR Part 11, EU Annex 11, and GAMP 5.You will work closely with Global QA, IT, regulatory affairs, and external vendors to ensure that the new ERP platform and other digital systems are inspection-ready, properly documented, and aligned with pharmaceutical regulations and expectations.Key Responsibilities
  • Develop and execute validation strategies for GxP-relevant systems in accordance with GAMP 5 and biotech/pharma industry standards.
  • Author and review validation documentation such as validation plans, IQ/OQ/PQ protocols, traceability matrices, and summary reports.
  • Ensure systems comply with electronic records and signature regulations (21 CFR Part 11, Annex 11).
  • Perform risk assessments for new systems, upgrades, and system changes, and integrate validation into the change management process.
  • Maintain audit-ready documentation and support both internal and external audits, including regulatory inspections.
  • Address audit findings and contribute to corrective and preventive actions (CAPAs).
  • Collaborate with QA, regulatory, manufacturing, and IT stakeholders as well as external vendors to align on compliance and validation requirements.
  • Provide training and guidance on validation procedures, regulatory expectations, and documentation standards.
Your ProfileWe are looking for a structured and proactive specialist who thrives in a regulated environment and enjoys collaborating across functions.You bring:
  • A Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Science, or similar.
  • 5+ years of experience in IT compliance, system validation, or QA in biotech, pharma, or another regulated industry.
  • Solid knowledge of GxP, GAMP 5, 21 CFR Part 11, and EU Annex 11.
  • Experience with computerized system validation (CSV) and quality documentation.
  • Familiarity with enterprise platforms like ERP, MES, LIMS, or QMS.
  • Excellent analytical, documentation, and communication skills.
  • Full professional proficiency in English.
As a person, you are detail-oriented and accountable – and you take pride in building systems and documentation that stand up to inspection and support safe, efficient operations.FIND THIS INTERESTING? APPLY NOW!Are you ready to take the next step in your career? The position will be open until September 28th, 2025, but we are applying ongoing selection so do not hesitate to send us your application.Our Global IS/IT team is primarily based in Malmö, but we also welcome applicants located near our other sites in Strasbourg, Braine, or Ambernath, provided you are within commuting distance.For more information, please contact Krister Svärd at Swedish applicants 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