Head of projects - Leading fine chemicals & pharma MNC

Michael Page; Mumbai Suburban; On-site; INR 4,000,000 - 7,000,000; Full time

Benefits offered by this job

Attractive remuneration

Job summary

Michael Page is seeking a project leader for GMP pharmaceutical facilities in India. You will oversee engineering and manufacturing projects from design through commercial operation, coordinating Stage-Gate reviews, budgets, risks, and schedules with cross-functional teams.

You will ensure compliance with Schedule M, ICH Q7, WHO GMP, and applicable FDA/EDQM standards, handling regulatory interactions with CDSCO and state authorities.

Qualifications

• Experience delivering GMP-certified pharma facilities from design to operation.
• Strong knowledge of GMP regulatory frameworks and site compliance.
• Familiarity with qualification/validation lifecycle (URS, DQ, IQ, OQ, PQ).

Responsibilities

• Plan and oversee pharma engineering projects from start to finish.
• Lead stage-gate processes with budget, risk, and schedule oversight.
• Ensure conformance with Schedule M, ICH Q7, WHO GMP guidelines and relevant FDA/EDQM standards.
• Coordinate with CDSCO and state regulators; manage inspection readiness.
• Initiate GMP documentation early and align with construction timelines.
• Manage budgets, timelines, and cross-functional collaboration to meet goals.
• Ensure safety and quality standards and smooth project handover.

Skills

GMP knowledge

Project management

Cross-functional teamwork

Regulatory compliance

Job description

• Only candidates from Pharma or Chemical industry must apply


• Only candidates who've worked on GMP certified pharma projects apply

About Our Client

Our client is a European MNC with around 15 plants worldwide.

Job Description

Reporting to the Head of Operations you will:

• Plan and oversee engineering and manufacturing projects from start to finish.


• Lead the stage-gate process in coordination with the Steering Committee and prepared gate review packages, including budget status, risk register, and schedule performance.


• Ensure all engineering design, construction, and commissioning activities are executed in full conformance with Schedule M (D&C Act 1940 & Rules 1945), ICH Q7, WHO TRS 957 / 885 / 1010, and applicable FDA and EDQM standards.


• Serve as the primary project contact for CDSCO, Maharashtra state regulatory bodies, and environmental/factory licensing authorities; manage inspection readiness throughout construction.


• Ensure GMP documentation (URS, DQ, FAT/SAT protocols, SOP framework) is initiated early and completed in parallel with construction - not retrospectively.


• Manage budgets, timelines, and resources effectively.


• Work closely with cross-functional teams to meet project goals.


• Ensure compliance with safety and quality standards.


• Identify and resolve project challenges quickly.


• Ensure smooth handover of completed projects to operations teams.

The Successful Applicant

We're looking for someone who has:

• Demonstrated track record of having delivered at least one GMP-certified pharmaceutical manufacturing facility from design through to commercial operation, with a project value of USD 10 million or above.


• Deep, working knowledge of GMP regulatory frameworks - specifically Schedule M, ICH Q7, and WHO GMP guidelines - as applied to pharmaceutical manufacturing facility design and construction in India.


• Hands-on experience with pharmaceutical qualification and validation lifecycle: URS, DQ, IQ, OQ, PQ, and validation master planning.

What's on Offer

• Chance to work with a leading European MNC


• Attractive remuneration