Job Title: IS/IT Solution Manager QMS & RIM

Location: Ambernath, India

Job Type: Full Time

Reporting: Global Head Application & Integration Services

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.

Position Overview:

The IS/IT Solution Manager for QMS & RIM plays a central role in ensuring that QMS and Regulatory Information Management Applications are compliant, efficient, and supporting the business needs.

You will serve as the global Application specialist for key IS/IT platforms QUMAS (QMS), Veeva (RIM) and DocuBridge, support business stakeholders across sites, and contribute to the company’s digitalization and quality transformation initiatives. The role requires strong expertise within IS/IT Applications and processes supporting QA/RA, IS/IT solutions, GxP and regulatory compliance, Computerized System Validation (CSV). Deep knowledge within QMS Applications within GxP is a must. 

Key Responsibilities:

1. Application Support & Governance

• Serve as the global IS/IT application specialist for QMS and Regulatory Information Management Applications (i.e. QUMAS (QMS), Veeva RIM, and associated platforms).

• Collaboration and escalation of IS/IT-tickets internally and to external vendors.

• Creation of IS/IT Solution articles, manuals and instruction including training of IS/IT support teams.

• Ensure end-to-end application functionality, stability, availability, and regulatory compliance.

• Perform hands-on Application support, System Administration, Maintenance and Configuration Management.

• Lead and support validation (CSV) activities, including system qualifications, periodic reviews, access reviews, risk assessments, and change processes.

2. Operational Excellence & Support

• Provide day-to-day IS/IT application support within QMS and Regulatory Information Management Applications supporting the global QA/RA users.

• Monitor and resolve IS/IT incidents, service requests, and problems related to Global IS/IT Applications (i.e. Qumas and Veeva RIM.)

• Drive process compliance changes related to changes within the Applications.

• Ensure timely and accurate documentation of system activities, including design documents, functional specifications, GSOPs, and validation artifacts.

• Manage IS/IT Application license utilization, maintenance fees, and initiate procurement actions where required.

3. Business Solutions Development

• Design, configure, and implement Application enhancements within QMS and Regulatory Information Management Applications to optimize workflows, compliance outcomes, and user experience.

• Drive the continues improvement within the Application area together with QA/RA business stakeholders.

• Collaborate with the business stakeholders in managing and executing the Application roadmap within Global QA/RA applications.

4. Compliance, Validation & Quality Management

• Maintain the validated state of QA/RA Applications through robust change control, documentation, and lifecycle management.

• Support internal and external audits and inspections by providing Application documentation and demonstrating compliance.

• Manage, coordinate, and close CAPAs related to QMS and Regulatory Information Management Applications with a focus on root-cause and long-term prevention.

5. Governance, Change & Release Management

• Play an active role in IS/IT Change Advisory Board (CAB) meetings and other global governance forums.

• Lead change and release management activities, including risk assessment, testing, validation, and deployment readiness.

• Ensure adherence to IS/IT governance standards and global QA/RA process frameworks.

6. Stakeholder Engagement & Collaboration

• Close collaboration with Global QA, RA, IS/IT, validation teams, manufacturing, and external vendors.

• Build strong relationships with global stakeholders and effectively manage expectations, priorities, and deliverables.

• Participate in and lead Governance forums.

• Collaborate with third‑party IS/IT Application vendors to ensure SLA compliance, effective communication, and timely execution of activities.

7. Data Governance, Reporting & Insights

• Ensure data integrity, compliance, traceability, and security across all QA/RA platforms.

• Monitor platform performance, system adoption, and usage trends to identify improvement opportunities.

• Proactively manage system capacity, license consumption, and ongoing operational readiness.

Required Skills & Qualifications:

• Master’s degree in computer science, Information Systems, or related field.

• A minimum of 5 years as an IS/IT Application specialist within QMS and Regulatory Information Management Applications within Life science/CDMO is a must.

• Knowledge in QA and RA processes within the pharmaceutical/CDMO industry.

• Strong experience in validation of QMS and Regulatory Information Management Applications (computer system validation, CSV)

• Experience working in GxP-regulated environments.

• Proven ability to work in structured, process-driven environments, handling change management and continuous improvement.

• Excellent stakeholder management skills, collaborating with QA and RA departments, validation teams, and IT professionals across global sites.

• Strong problem-solving and analytical skills, with a proactive mindset towards process optimization and system improvements.

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.