Validation Manager

Validation Manager

Overview

Our client - an Artificial Intelligence (AI) focused IT Services company that helps Enterprises discover and implement Artificial Intelligence enabled solutions to improve business processes and supplant human effort with human intuition - is seeking to hire a Validation Manager.

They help businesses unlock growth through AI, digital engineering, and data-driven consulting. They design and deliver tailored solutions—ranging from strategy to implementation—that drive real outcomes. What sets them apart is their blend of deep domain expertise, cutting-edge AI innovation, and a people-first approach that ensures organizations not only adopt AI but truly thrive with it.

Experience

18+ years of overall experience, with strong experience in Computer System Validation (CSV), GxP validation, and project management within the Life Sciences / Pharmaceutical domain.

Location-Bangalore / Noida

Work Mode: Hybrid

Role Overview

We are looking for an experienced Validation Project Manager to lead and manage validation and compliance projects for clients in the Pharmaceutical / Life Sciences domain.

The ideal candidate should have strong experience in Computer System Validation (CSV), GxP, regulatory compliance, risk management, and project delivery, along with the ability to manage client stakeholders and cross-functional teams.

Key Responsibilities

• Lead end-to-end delivery of Computer System Validation (CSV) and GxP compliance projects.
• Manage validation projects from planning and requirements through testing, validation, release, and project closure.
• Develop and manage project plans, timelines, milestones, deliverables, dependencies, and resources.
• Lead cross-functional teams comprising Validation, QA, Business Analysts, Testing, IT, Engineering, and business stakeholders.
• Define and maintain validation strategies, plans, and project documentation.
• Ensure projects comply with applicable GxP, FDA, EMA, and other regulatory requirements.
• Manage project risks, issues, assumptions, dependencies, and mitigation plans.
• Drive project governance, status reporting, stakeholder reviews, and steering committee meetings.
• Coordinate with clients and internal teams to ensure timely completion of validation deliverables.
• Review and oversee validation documentation, including:
• Validation Master Plans
• Validation Plans
• User Requirements Specifications (URS)
• Functional / Technical Specifications
• Risk Assessments
• IQ/OQ/PQ documentation
• Traceability Matrix
• Test Scripts and Test Evidence
• Validation Summary Reports
• Ensure deviations, CAPAs, change controls, and other quality events are appropriately tracked and resolved.
• Monitor project progress against agreed scope, schedule, budget, quality, and client expectations.
• Identify opportunities to improve validation processes, methodologies, and delivery efficiency.
• Support client discussions, requirement workshops, project estimation, and solution planning.
• Manage multiple projects or workstreams simultaneously, depending on business requirements.
• Mentor validation and project team members and contribute to capability development.

Required Technical & Domain Skills

• Strong experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA).
• Good understanding of GxP requirements and regulated Life Sciences environments.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, and data integrity principles.
• Experience with validation methodologies such as risk-based validation.
• Understanding of SDLC, STLC, Change Management, Incident Management, and Quality Management processes.
• Experience in managing validation documentation and audit-ready deliverables.
• Good understanding of IQ/OQ/PQ, UAT, traceability, risk assessment, deviations, CAPA, and change control.
• Experience working with regulated applications such as:
• 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 project planning, scheduling, estimation, and resource management skills.
• Experience managing project risks, issues, dependencies, and escalations.
• Strong stakeholder and client management capabilities.
• Experience working with distributed/global teams.
• Ability to manage project scope, timelines, budgets, and deliverables.
• Experience with Agile, Waterfall, or hybrid delivery methodologies.
• Strong communication, presentation, negotiation, and leadership skills.

Regulatory & Compliance Knowledge

Good understanding of applicable Life Sciences regulations and guidelines, including:

• FDA 21 CFR Part 11
• EU GMP Annex 11
• GAMP 5
• Data Integrity / ALCOA+ principles
• GxP requirements
• Electronic Records and Electronic Signatures
• Computer System Validation / Assurance
• Audit and inspection readiness

Good to Have

• Experience working with global Pharmaceutical / Biotech / Life Sciences clients.
• Exposure to AI/ML validation or emerging technology validation.
• Experience with cloud-based GxP applications and platforms.
• Exposure to tools such as Veeva, TrackWise, MasterControl, ServiceNow, SAP, LIMS, or MES.
• PMP / PRINCE2 / Scrum Master certification.
• Experience in consulting and client-facing roles.
• Experience in pre-sales, estimation, proposal preparation, or account growth.

Key Competencies

• Validation & Compliance Expertise
• Project & Program Management
• Life Sciences / Pharma Domain Knowledge
• Client & Stakeholder Management
• Risk & Issue Management
• Quality & Regulatory Compliance
• Team Leadership
• Communication & Presentation
• Problem Solving
• Delivery Management