10.0 years
0.0 Lacs P.A.
Pune, Maharashtra, India
Posted:1 week ago| Platform:
On-site
Full Time
Role Overview: Experienced Solution Architect to design and deliver scalable, compliant, and innovative solutions within the Life Sciences domain. Will work closely with stakeholders across R&D, Clinical, Regulatory, and Commercial functions to architect systems that meet business goals while ensuring adherence to regulatory standards such as GxP and 21 CFR Part 11. Key Responsibilities: Solution Design & Architecture: Architect end-to-end Life Sciences solutions, including system integrations, data workflows, and cloud enablement. Create high-level and detailed solution blueprints for platforms such as Veeva, SAP, LIMS, and other clinical/quality systems. Stakeholder Collaboration: Engage with business and IT teams to translate clinical, regulatory, and commercial needs into secure, scalable technical architectures. Regulatory Compliance: Ensure architectural solutions align with GxP, HIPAA, and 21 CFR Part 11 requirements. Support audit readiness and validation documentation. Technical Leadership: Guide engineering teams through design, development, and implementation. Align technology strategy with business outcomes. Documentation & Governance: Produce architecture documents, interface specifications, and compliance checklists. Participate in solution reviews and change control. Preferred Qualifications: 10+ years in IT with 3–5 years in Solution Architecture roles Experience in Life Sciences/Pharma/MedTech across functions (Clinical, Regulatory, Quality, etc.) Strong knowledge of SDLC, Agile/Waterfall, API/Microservices, Cloud (Azure/AWS) Familiarity with platforms like Veeva Vault, SAP, LIMS, and EDC tools Working knowledge of data integration standards (e.g., HL7, FHIR) Strong understanding of compliance standards (GxP, 21 CFR Part 11) Excellent communication and stakeholder management skills Show more Show less
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Pune, Maharashtra, India
0.0 - 0.0 Lacs P.A.