Pharma R&D Functional SME

• *Job Description**
• ------------------

• *Your Role**
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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**
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### **Experience**

• **15–18 years of experience** in the Pharmaceutical and Life Sciences industry.

Strong 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 industry or platform certifications.

• *What You’ll Love About Working Here**
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• Opportunity to work with leading global pharmaceutical and life sciences organizations.
• Exposure to cutting\-edge digital transformation initiatives across R\&D, Clinical, Manufacturing, and Quality functions.
• Collaborative, innovation\-driven culture focused on continuous learning and growth.
• Access to upskilling opportunities in Life Sciences, Cloud, Data, AI, and emerging technologies.

• *About Capgemini in India**
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Capgemini is an AI\-powered global business and technology transformation partner, helping organizations realize their future through technology, data, and people. With nearly 60 years of heritage, Capgemini is a responsible and diverse organization with **420,000 team members across more than 50 countries**. The Group reported **2024 global revenues of €22\.1 billion**.

• *Make it real \|** **www.capgemini.com/in\-en**