About the role

Job Title: IS/IT Solution Manager QMS & RIM

Location: Ambernath, Thane , India

Job Type: Full Time Reporting: Global Head Application & Integration Services, Global IS/IT 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. Y

ou 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: 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. Locations Ambernath Our Core Values INNOVATION - We are curious and explore new ways. - We are also ambitious and find solutions.

EXCELLENCE - We have a strong technical knowledge, and we deliver results - We lead quality in everything we do - We are adaptable and customer focused TRUST - We believe in teamwork and collaboration. - We lead by example and accept responsibility - We are transparent and we show integrity.

About PolyPeptide Group 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. Founded in 1996 Co-workers Around 1,200 Apply for this job Ambernath Solution Manager QA & RA Personal information Apply with LinkedIn First name*Required Last name*Required Email*Required Phone*Required Upload CV*Required Drop your file or upload Additional files Drop your file or upload Cover letter*Required Required.

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