Verified Job
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Solution Architecture roles with Life sciences experience
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#577204
Full Time
Job Description
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
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
