. Presales & RFP Solutioning 

• Analyze RFPs and RFIs to determine GxP applicability, scope, regulatory expectations and compliance requirements. 

• Identify GxP requirements across applications, infrastructure, cloud, OT/shopfloor and platform environments. 

• Develop GxP solution approaches, scope, assumptions, dependencies, exclusions and deliverables. 

• Prepare customer clarification questions to resolve gaps in GxP scope, ownership, volumes, tools and responsibilities. 

• Develop proposal responses, solution decks, operating models, transition approaches and customer-ready solution narratives. 

• Participate in solution-defense sessions and customer presentations. 

2. GxP Solution Architecture 

• Define risk-based validation and qualification approaches aligned with GAMP 5, FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles. 

• Develop lifecycle approaches covering validation planning, risk assessment, requirements, testing/qualification, traceability, release and maintenance of the validated state. 

• Define GxP governance models for transformation, transition and BAU managed services. 

• Establish clear ownership boundaries between customer Quality, GxP/CSV teams and technical delivery towers. 

3. Effort Estimation & Commercial Support 

• Develop GxP effort and FTE sizing models based on the system landscape, risk classification, document/test volumes and operational demand. 

• Define onsite/offshore and L2/L3/SME resource models. 

• Provide inputs for pricing and commercial discussions. 

• Document assumptions and dependencies that protect the solution from undefined or unbounded GxP scope. 

• Optimize solutions while maintaining regulatory and quality expectations. 

4. Customer Engagement & Solution Defense 

• Lead or participate in customer discovery workshops. 

• Understand customer Quality Systems, validation methodologies, tools and operating model. 

• Present and defend the proposed GxP solution. 

• Explain complex regulatory and validation requirements in clear business language. 

• Collaborate with customer QA, IT, Security, Infrastructure, Application, Cloud and OT stakeholders. 

5. Internal Collaboration & Knowledge Management 

• Work with Sales, Account teams, GRC leadership, delivery teams, technical towers and commercial teams to build integrated solutions. 

• Coordinate technical inputs required for solution development. 

• Support transition of won opportunities from presales to delivery, including knowledge transfer and handover of assumptions and commitments. 

• Maintain reusable GxP proposal content, solution accelerators, estimation models, case studies and knowledge repositories. 

GxP & Regulatory Knowledge 

• GxP and regulated Life Sciences environments 

• Computer System Validation (CSV) and Computer Software Assurance (CSA) 

• GAMP 5 

• FDA 21 CFR Part 11 and EU Annex 11 

• Data Integrity and ALCOA+ principles 

• Risk-based validation and qualification 

• Change Control, Deviation and CAPA concepts 

• Periodic Review and maintenance of the validated/qualified state 

• Application validation and infrastructure qualification 

Presales & Consulting Skills 

• RFP/RFI analysis and response 

• Solution architecture and proposal development 

• Customer discovery and requirement analysis 

• Effort estimation and resource sizing 

• Solution assumptions, dependencies and commercial inputs 

• Solution presentation and defense 

• Executive stakeholder communication 

• Strong written and verbal communication