Solution Manager QA & RA

Job Title: Solution Manager QA & RA

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 Solution Manager for QA & RA plays a central role in ensuring that global Quality Assurance (QA) and Regulatory Affairs (RA) applications and processes are compliant, efficient, and aligned with organizational needs. This role bridges business and IS/IT functions, emphasizing system governance, compliance, validation, and process optimization rather than deep technical development.

You will serve as the global system owner for key platforms such as QUMAS and Veeva, support business stakeholders across sites, and contribute to the company's digitalization and quality transformation initiatives. The role requires strong expertise in QA/RA processes, GxP and regulatory compliance, and validated systems management.

Key Responsibilities:

• Application Ownership & Technical Governance
• Serve as the global technical and application owner for QA/RA systems, including QUMAS, Veeva, and associated platforms.
• Ensure end-to-end application functionality, stability, availability, and regulatory compliance.
• Maintain in-depth knowledge of system architecture, integrations, configuration dependencies, and platform capabilities.
• Oversee system administration, maintenance, configuration management, and operational monitoring.
• Lead and support validation activities, including system qualifications, periodic reviews, risk assessments, and change validations.
• Operational Excellence & Support
• Provide day-to-day application support, troubleshooting, and issue resolution for global QA/RA users.
• Monitor and resolve incidents, service requests, and problems while driving long-term reduction of recurring issues.
• Ensure timely and accurate documentation of system activities, including design documents, functional specifications, GSOPs, and validation artifacts.
• Manage license utilization, maintenance fees, and initiate procurement actions where required.
• Ensure business continuity and system readiness during planned IS/IT service windows and maintenance activities.
• Business Solutions Development
• Assess business needs and translate them into clear functional and technical requirements for digital QA/RA processes.
• Design, configure, and implement system enhancements to optimize workflows, compliance outcomes, and user experience.
• Drive the development of new modules, features, and integrations to strengthen the global QA/RA digital ecosystem.
• Contribute to the design and execution of the global digital roadmap, ensuring alignment with business strategy and regulatory expectations.
• Compliance, Validation & Quality Management
• Ensure system configurations and workflows comply with global regulatory standards (FDA, EMA, ICH, GxP).
• Maintain the validated state of QA/RA systems through robust change control, documentation, and lifecycle management.
• Support internal and external audits and inspections by providing system documentation and demonstrating compliance.
• Manage, coordinate, and close CAPAs related to QA/RA applications with a focus on root-cause and long-term prevention.
• Governance, Change & Release Management
• Play an active role in Change Advisory Board (CAB) meetings and other global governance forums.
• Oversee 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.
• Develop and maintain system SOPs, GSOPs, technical documentation, and controlled records.
• Stakeholder Engagement & Collaboration
• Act as the primary liaison between 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 cross-functional governance forums, quality councils, and process harmonization initiatives.
• Collaborate with thirdparty vendors to ensure SLA compliance, effective communication, and timely execution of activities.
• Data Governance, Reporting & Insights
• Ensure data integrity, compliance, traceability, and security across all QA/RA platforms.
• Develop dashboards, KPIs, and reports to support quality metrics, regulatory submissions, and management reviews.
• Monitor platform performance, system adoption, and usage trends to identify improvement opportunities.
• Proactively manage system capacity, license consumption, and ongoing operational readiness.
• Training, Support & User Enablement
• Deliver system training, onboarding, and capabilitybuilding programs for global QA/RA users.
• Develop user guides, SOPs, training materials, and bestpractice documents.
• Champion change initiatives related to QA/RA transformations, ensuring strong adoption and sustained behavioral change.
• Provide expert guidance to enhance digital literacy and process alignment across sites.
• Strategic Contribution & Global Process Ownership
• Contribute to the long-term QA/RA digital strategy, lifecycle planning, and technology enhancement roadmap.
• Participate in setting global standards for application maintenance, data governance, and system compliance.
• Lead or support global implementations, system rollouts, upgrades, and harmonization initiatives.
• Develop communication materials and strategic updates to strengthen organizational awareness and stakeholder buy-in.
  
  

Required Skills & Qualifications:

Qualifications:

• Master's degree in, Computer Science, Information Systems, or related field.
• +5 years of experience in Quality Assurance & Regulatory Affairs in the pharmaceutical/CDMO industry.
• Strong knowledge of Quality Assurance & Regulatory Affairs, with expertise in validated IT systems and computer system validation (CSV).
• Experience working in GxP-regulated environments, with a deep understanding of governance, risk assessments, and compliance requirements.
• 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.
Skills Required
Gxp, Governance, Regulatory Affairs, Quality Assurance