As a Pharma R&D; Functional SME, you will be responsible for driving Pharma Application Management Services (AMS) assessments, solutioning, proposal development, and delivery excellence for global Life Sciences clients. You will leverage your deep domain expertise across Pharma R&D;, Laboratories, Clinical, Manufacturing, Quality, Regulatory, and Commercial functions to help organizations optimize application portfolios, modern
In this role, you will:
- Lead Pharma AMS assessments, portfolio analysis, and application rationalization initiatives.
- Conduct stakeholder workshops to understand business processes, application landscapes, and transformation objectives.
- Support proposal development, RFP/RFI responses, and client presentations.
- Define AMS operating models, transition approaches, SLA/KPI frameworks, and risk mitigation strategies
Your Profile
Experience
- 15–18 years of experience in the Pharmaceutical and Life Sciences industry.
Solid understanding of Life Sciences processes across:
- Pharma R&D;
- Laboratory Operations
- Technical Operations (TechOps)
Hands-on experience with Pharma and R&D; platforms including:
- Preclinical Systems
- Lab Informatics
- ELN (Electronic Lab Notebook)
- LIMS
- GeneData
- Benchling
- BIOVIA
- Revvity
AMS & Solutioning Expertise
- Application inventory assessment and portfolio analysis.
- Effort estimation and resource planning.
- SLA/KPI framework design and governance.
- Modernization recommendations and transformation roadmap development.
- Vendor evaluation and stakeholder management.
Regulatory & Compliance
Strong understanding of:
- GxP
- GAMP5
- 21 CFR Part 11
- Annex 11
- Data Integrity
- Computer System Validation (CSV)
- Validation Lifecycle Management
- Audit Readiness Requirements
Preferred Qualifications
- Experience working in global delivery environments.
- Knowledge of Agile and SAFe methodologies.
- Exposure to Cloud Platforms, AI, Data & Analytics solutions.
- Relevant industr
📌 Pharma R&D Functional SME (Pune)
🏢 Capgemini
📍 Pune
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