Presales - Team Member

Job Summary

We are looking for an experienced GxP Presales & Solution Consultant to support Life Sciences opportunities within the GRC practice. The role is responsible for understanding customer requirements, assessing GxP applicability, designing compliant and commercially viable solutions, supporting RFP/RFI responses, estimating GxP effort, and presenting and defending solutions with customers.

The role requires strong knowledge of GxP, Computer System Validation (CSV), Computer Software Assurance (CSA), GAMP 5, FDA 21 CFR Part 11, EU Annex 11, Data Integrity and risk-based validation/qualification, combined with strong presales, stakeholder-management and customer-facing capabilities.

Key Responsibilities

. Presales & RFP Solutioning

• Analyze RFPs and RFIs to determineGxPapplicability, scope, regulatory expectationsand compliance requirements.

• IdentifyGxPrequirements across applications, infrastructure, cloud, OT/shopfloorand platform environments.

• Develop GxPsolution approaches, scope, assumptions, dependencies, exclusionsand deliverables.

• Prepare customer clarification questions to resolve gaps in GxPscope, ownership, volumes, toolsand responsibilities.

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

• Participate in solution-defense sessions and customer presentations.

2. GxPSolution Architecture

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

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

• Define GxPgovernance models for transformation, transitionand BAU managed services.

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

3. Effort Estimation & Commercial Support

• Develop GxPeffort and FTE sizing models based on the system landscape, risk classification, document/test volumesand 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 GxPscope.

• Optimizesolutions while maintainingregulatory and quality expectations.

4. Customer Engagement & Solution Defense

• Lead or participatein customer discovery workshops.

• Understand customer Quality Systems, validation methodologies, toolsand operating model.

• Present and defend the proposed GxPsolution.

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

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

5. Internal Collaboration & Knowledge Management

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

• Coordinate technical inputs requiredfor solution development.

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

• Maintain reusable GxPproposal content, solution accelerators, estimation models, case studiesand knowledge repositories.

Skill Requirements

GxP& Regulatory Knowledge

• GxPand 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, dependenciesand commercial inputs

• Solution presentation and defense

• Executive stakeholder communication

• Strong written and verbal communication

Other Requirements

NA