Job Title: IS/IT Validation and Compliance Specialist
Location: Ambernath, India
Job Type: Full Time
Reporting: CISO, Global IT Governance
About PolyPeptide Group:
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 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 VALUES
Trust: 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.
Position Overview
PolyPeptide is on a transformative growth journey—expanding globally, investing in new technologies, and strengthening its governance, risk, and compliance capabilities across the organization.
We are seeking an IS/IT Validation and Compliance Specialist to support and further enhance our global IT compliance framework. This role combines deep understanding of regulatory and compliance requirements (GAMP 5, ISO27001, NIS2, GMP) with a proactive mindset to challenge existing practices, drive continuous improvement, and enable a modern, agile, and inspection‑ready Global IS/IT function.
You will be part of the Cybersecurity and Service Excellence team within Global IS/IT, reporting operationally to the IT Compliance Manager. The role involves close collaboration with QA, risk owners, solution managers, and global stakeholders across multiple sites and time zones. Our approach is compliance through excellence, ensuring that IT systems, policies, and processes meet the highest regulatory and quality standards while enabling business growth.
In this role, you will support and continuously develop the Governance, Risk, and Compliance (GRC) framework for Global IS/IT, ensuring alignment with ISO27001, NIS2, and applicable GMP requirements.
You will balance structured compliance and documentation activities with a forward‑looking, improvement‑driven approach, helping the organization evolve while maintaining constant audit and inspection readiness.
Key Responsibilities
- Participate in ISO27001:2022 certification activities, including planning, control operation, monitoring, reviews, and documentation.
- Maintain and govern global SOPs, policies, and templates in compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11 requirements.
- Support internal and external audits and inspections, managing auditor requirements and ensuring ongoing compliance adherence.
- Monitor and support IT risk management activities, including maintenance of the IT risk register and coordination of mitigation actions with risk owners.
- Support the implementation and operationalization of new regulatory requirements (e.g., NIS2) relevant to Global IS/IT.
- Participate in global IT compliance forums and meetings, supporting stakeholders across regions and time zones.
- Perform System Impact Assessments and risk assessments for computerized systems.
- Support Solution Managers in performing user baseline reviews and audit trail reviews.
- Develop and deliver training programs on IT compliance, GMP requirements, and supplier qualification processes for IS/IT employees and consultants.
- Facilitate and support the supplier qualification and re‑qualification process.
- Participate in computerized system validation (CSV) activities, including change control and periodic system reviews.
- Provide backup support to the IS/IT Asset and License Specialist during peak workload periods, vacation, or other absences.
Required Skills & Qualifications
Educational Qualification
- A degree in Computer Science, Information Technology, or a related field; or equivalent relevant hands‑on experience.
Professional Experience
- 2–3+ years of experience in a GMP‑regulated or similarly regulated industry.
- 2–3+ years of hands‑on experience with ISO27001:2022 (lead implementer or internal/external auditor certification is an advantage).
- Strong working knowledge of GAMP 5, NIS2, and information security standards.
- Excellent written and verbal communication skills in English, with the ability to collaborate effectively across global teams and time zones.
Soft Skills & Behavioral Competencies
- Strong attention to detail with a high level of quality, compliance, and risk awareness.
- Structured, analytical, and methodical approach to work, with the ability to manage multiple priorities in a regulated environment.
- Proactive and improvement‑oriented mindset, with the confidence to challenge existing practices constructively.
- Strong communication and interpersonal skills, enabling effective collaboration with technical, quality, and business stakeholders.
- Ability to influence and advise stakeholders at different organizational levels without direct authority.
- High level of integrity, accountability, and confidentiality when handling compliance‑critical information.
- Self‑driven and capable of working independently, while contributing effectively within a global, cross‑functional team.
- Adaptable and resilient in a dynamic, evolving organization with high regulatory and inspection expectations.
Why Join Us at PolyPeptide Group:
PolyPeptide Group offers an exciting opportunity to work at the forefront of peptide-based therapeutics, a rapidly growing and innovative segment of the pharmaceutical industry. As a key member of PolyPeptide team, you will have the opportunity to contribute to a company that is dedicated to the success of its clients and the advancement of peptide science. Join us and be part of a global organization that is shaping the future of life-saving therapies.
