Validation Project Manager

DMAIC Academy & Consultancy; Bengaluru; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

DMAIC Academy & Consultancy is seeking an experienced Validation Manager to lead end-to-end CSV/CSA and GxP projects for pharmaceutical clients. You will drive regulatory compliance, risk management, and cross-functional team leadership across Validation, QA, IT, and Engineering.

You will manage client communications, establish validation strategies, and ensure timely delivery of test scripts, evidence, and validation reports. Strong experience in FDA/EMA guidelines is required.

Qualifications

• Experience in end-to-end CSV/CSA and GxP compliance projects.
• Strong regulatory compliance knowledge for Life Sciences/pharma.
• Risk-based validation and quality event management.
• Experience with SDLC/STLC, change management and incident management.
• Proven track record in client/stakeholder management and leading cross-functional teams.
• Experience with Agile, Waterfall, or Hybrid delivery models.

Responsibilities

• Lead end-to-end CSV/CSA and GxP compliance projects from planning to closure.
• Manage scope, timelines, milestones, deliverables, risks, and budgets.
• Lead cross-functional teams across Validation, QA, IT, Engineering, and Business.
• Define validation strategies, plans, and governance, with status reporting.
• Ensure timely delivery of validation activities and change controls.
• Review/oversee VMPs, URS, IQ/OQ/PQ, UAT, and Traceability matrices.
• Mentor validation teams and manage multiple projects.

Skills

CSV/CSA experience

GxP compliance

risk management

project delivery

stakeholder management

cross-functional leadership

SDLC/STLC

change control

quality management

delivery management

Tools

Veeva

TrackWise

MasterControl

ServiceNow

SAP

LIMS

MES

Job description

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.
• Good 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.
• Consulting/client-facing experience.
• Experience in pre-sales, estimation, proposal preparation, or account growth.

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