Presales Team Member

Job description

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 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. Skill Requirements 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 Other Requirements NA Apply now Information at a Glance Why HCLTech? At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first. HCLTech is a global technology company, home to more than 223,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2026 totaled $14.8 billion. Disclaimer Privacy Statement Terms of use Sitemap Raise a Grievance We use cookies on our site. Please read more about cookies policy here. Opens in a new tab. Opens in a new tab. Opens in a new tab. Opens in a new tab. Opens in a new tab. Opens in a new tab. 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