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 1 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 2 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 3 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 4 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 5 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 6 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 third party 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 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 8 Training Support User Enablement Deliver system training onboarding and capability building programs for global QA RA users Develop user guides SOPs training materials and best practice 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 9 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 cutting-edge 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

📌 Solution Manager Qa & Ra (Pahalgam)
🏢 PolyPeptide Group
📍 Pahalgam