Project Manager

Project Manager

Job Title

Project Manager

Industry Domain

Pharmaceutical / Life Sciences (GxP-regulated Manufacturing)

Experience Required

8 to 12+ years in project/program management roles

Employment Type

Full-time

Location

Chennai

Role Overview

We are looking for an experienced Project Manager to lead the end-to-end delivery of teddnnnnchnology and engineering projects for a pharmaceutical manufacturing client. The candidate will own project planning, scope, budget, schedule, risk, and stakeholder management across engineering, quality/validation, and IT teams, ensuring solutions are delivered on time, within budget, and in full compliance with applicable regulatory requirements, from estimation and solution design through build, testing, qualification, and go-live.

Key Responsibilities

• Own overall project planning, scheduling, budgeting, and resource allocation across the project lifecycle.
• Define and manage project scope, deliverables, milestones, and acceptance criteria in coordination with client and internal stakeholders.
• Lead cross-functional project teams comprising engineers, technical consultants, validation specialists, and IT infrastructure teams.
• Drive project governance, including status reporting, steering committee updates, RAID (Risks, Assumptions, Issues, Dependencies) logs, and escalation management.
• Coordinate effort and cost estimation, solution proposals, and contract/SOW management for client engagements.
• Ensure project execution aligns with applicable quality, regulatory, and data integrity requirements, working closely with quality and validation teams.
• Oversee planning and tracking of validation/testing lifecycle documentation (URS, FRS/FDS, DQ, IQ, OQ, PQ, Traceability Matrix) where applicable.
• Manage change control, scope changes, and variation requests through formal client change management processes.
• Coordinate testing, commissioning, cutover, and post-go-live support activities, ensuring minimal disruption to business/plant operations.
• Track project financials including budget vs. actuals, invoicing milestones, and margin/profitability of the engagement.
• Facilitate coordination between technical, functional, and infrastructure teams for seamless project delivery.
• Manage vendor, subcontractor, and third-party coordination where applicable (hardware, licensing, integration partners).
• Conduct regular client reviews, manage stakeholder expectations, and ensure high levels of client satisfaction.
• Support knowledge transfer, training coordination, and handover documentation to client operations and support teams.
• Identify opportunities for process improvement and contribute to organizational project management best practices.

Required Skillset

• Proven project management experience delivering technology, engineering, ideally in a regulated manufacturing environment.
• Strong understanding of project management methodologies (Waterfall, Agile/Hybrid) and tools (MS Project, Jira, Smartsheet, or equivalent).
• Working knowledge of technical/engineering system architecture sufficient to engage credibly with technical teams and clients.
• Experience managing project budgets, resource planning, and financial tracking for multi-month/multi-phase engagements.
• Familiarity with testing, commissioning, and qualification/validation lifecycle stages in regulated industries.
• Strong risk management, change control, and issue-resolution skills in complex, multi-stakeholder environments.
• PMP, PRINCE2, or equivalent project management certification is a plus.

Pharmaceutical / Regulatory Domain Expertise (Preferred)

• Prior experience managing projects within GxP-regulated manufacturing environments.
• Working knowledge of GAMP 5 computerized system validation (CSV) lifecycle and its impact on project planning and timelines.
• Familiarity with 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+) requirements as they relate to project delivery and documentation control.

Certifications (Preferred)

• PMP (Project Management Professional) or PRINCE2 certification.
• GAMP 5 / CSV training certification.

Soft Skills & Other Requirements

• Excellent client-facing communication and stakeholder management skills, with the ability to engage confidently with quality, validation, and technical leadership.
• Strong leadership and team-management skills to coordinate multidisciplinary technical teams.
• Ability to prepare and present project plans, status reports, and executive summaries to client and internal leadership.
• Strong documentation discipline suited to regulated/validated environments.
• Sound judgment and decision-making ability under pressure, with strong problem-solving orientation for live project scenarios.