Validation Manager

Location: Bangalore / Noida

Work Mode: Hybrid

Experience: 18+ Years

Domain: Life Sciences / Pharmaceutical

Role Overview

We are looking for an experienced Validation Manager / Validation Project Manager to lead end-to-end Computer System Validation (CSV), Computer Software Assurance (CSA), GxP compliance, and validation projects for Pharmaceutical / Life Sciences clients.

The role requires strong expertise in CSV/GxP, regulatory compliance, risk management, project delivery, client/stakeholder management, and cross-functional team leadership .

Key Responsibilities

- Lead end-to-end CSV/CSA and GxP compliance projects from planning and requirements through testing, validation, release, and closure.
- Manage project scope, timelines, milestones, deliverables, dependencies, resources, budget, risks, issues, and escalations .
- Lead cross-functional teams across Validation, QA, Business Analysis, Testing, IT, Engineering, and Business .
- Define and maintain validation strategies, plans, project documentation, governance, status reporting, and steering committee reviews .
- Manage client and internal stakeholder communication and ensure timely delivery of validation activities.
- Review/oversee Validation Master Plans, Validation Plans, URS, Functional/Technical Specifications, Risk Assessments, IQ/OQ/PQ, UAT, Traceability Matrix, Test Scripts/Test Evidence, and Validation Summary Reports .
- Ensure appropriate tracking and resolution of deviations, CAPA, change controls, incidents, and quality events .
- Support requirements workshops, estimation, solution planning, process improvement, and delivery efficiency .
- Manage multiple projects/workstreams and mentor validation/project team members.

Mandatory Technical & Domain Skills
- Strong experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA) .




- Strong understanding of GxP and regulated Life Sciences/Pharmaceutical environments .
- Good knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, Data Integrity / ALCOA+ , Electronic Records and Electronic Signatures.
- Experience with risk-based validation methodologies.
- Understanding of SDLC, STLC, Change Management, Incident Management, and Quality Management processes.
- Strong experience managing validation documentation and audit-ready deliverables .
- Positive understanding of IQ/OQ/PQ, UAT, traceability, risk assessment, deviations, CAPA, and change control .

Regulated Applications Experience with one or more of the following:

LIMS, MES, ERP, QMS, EDMS/Document Management Systems, Laboratory Systems, Manufacturing Systems, Clinical/Safety Systems.

Project Management Skills

- Proven experience managing medium to large-scale validation programs/projects .
- Strong planning, scheduling, estimation, resource management, risk/issue/dependency management, and escalation skills.
- Strong client/stakeholder management and experience working with distributed/global teams.
- Experience with Agile, Waterfall, or Hybrid methodologies.
- Excellent communication, presentation, negotiation, leadership, and delivery management skills.

Good to Have
- Experience with global Pharma/Biotech/Life Sciences clients .
- Exposure to AI/ML validation, cloud-based GxP applications, or emerging technology validation .
- Exposure to Veeva, TrackWise, MasterControl, ServiceNow, SAP, LIMS, or MES .
- PMP / PRINCE2 / Scrum Master certification.
- Consulting/client-facing experience.
- Experience in pre-sales, estimation, proposal preparation, or account growth .

Key Competencies Validation & Compliance | CSV/CSA | GxP | Project/Program Management | Life Sciences/Pharma | Client & Stakeholder Management | Risk & Issue Management | Quality & Regulatory Compliance | Team Leadership | Delivery Management

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