Staff Business Analyst

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🕒 vor 2 Monaten

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🔴 Experte

🧐 Business-Analyst

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Syner-G BioPharma Group

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

Die Syner-G BioPharma Group ist der weltweit führende Anbieter von Lösungen in den Bereichen Chemie, Herstellung und Kontrolle (CMC), regulatorische Angelegenheiten und medizinisches Schreiben für den Biopharma-Sektor. Sie bieten umfassende Dienstleistungen, die Kunden durch die Komplexitäten der pharmazeutischen Entwicklung, regulatorische Einreichungen und Qualitätssicherung navigieren, um qualitativ hochwertige Ergebnisse sicherzustellen. Mit einem interdisziplinären Team integriert Syner-G wissenschaftliche, ingenieurtechnische und regulatorische Expertise, um die Arzneimittelentwicklung von der Vor-IND-Phase bis zur Phase nach der Zulassung zu unterstützen, was zeitgerechte Einreichungen und die Einhaltung der Patientensicherheit ermöglicht.

Beschreibung

• Lead end-to-end project management activities related to the implementation of ValGenesis, Kneat, or similar electronic validation lifecycle management platforms • Conduct detailed analysis of client validation processes to document user requirements, functional specifications, system requirements, and workflow needs • Plan and facilitate stakeholder workshops, discovery sessions, and Conference Room Pilots (CRPs) to assess current-state validation processes and define future-state solutions • Configure ValGenesis or Kneat software to meet client-specific requirements including workflows, templates, user roles, and validation objects • Develop business requirements, configuration documents, user stories, and related documentation needed to support system implementation • Partner with Quality, Validation, IT, Engineering, and Manufacturing stakeholders to ensure alignment on system functionality, compliance requirements, and operational needs • Develop and support testing activities including unit testing, functional testing, regression testing, and user acceptance testing (UAT) • Troubleshoot system issues, track resolutions, and coordinate with technical teams to ensure timely remediation • Prepare training materials and lead end-user training sessions to support system adoption and change management • Support go-live readiness activities including cutover planning, migration validation, and hypercare support • Ensure implemented solutions align with GxP expectations, validation best practices, and regulatory standards • Provide ongoing support, guidance, and continuous improvement recommendations for validation system usage • Contribute to best practices, process standards, and knowledge sharing across the project team

🎯 Anforderungen

• Bachelor’s degree in Computer Science, Life Sciences, Engineering, Industrial Engineering, Pharmaceutical Technology, or related field • 7–12 years of experience as a Business Analyst, Project Manager, or Validation SME supporting system implementation within the pharmaceutical or Life Sciences industry • Direct experience implementing Kneat or ValGenesis in a GxP environment is required • Experience working with validation, quality, compliance, or regulated manufacturing processes • Experience supporting cross-functional technical and validation workstreams on medium- to large-scale programs • Experience with CSV, GAMP 5, validation documentation, and electronic validation systems.

🏖️ Vorteile

• Competitive base salary • Annual incentive plan • Comprehensive benefits • Flexible paid time off • Company-paid holidays • Flexible working hours • Remote work options for most roles