Associate General Manager- Projects

Position Overview

The Assistant General Manager – Projects (API Pharma) will be responsible for leading and managing end-to-end project activities for Greenfield and Brownfield API (Active Pharmaceutical Ingredient) manufacturing facilities across domestic and international locations. The incumbent will oversee all phases of the project lifecycle—conceptualization, design, engineering, procurement, construction, installation, commissioning, and handover—ensuring timely delivery, adherence to budget, and full compliance with cGMP , EHS , and regulatory standards.

This role requires a highly skilled project management professional with a strong background in pharmaceutical engineering, process design, and cross-functional coordination, capable of managing complex projects while driving excellence in quality, safety, and cost-effectiveness.

Key Responsibilities

1. Project Planning & Execution

• Lead end-to-end project management for new API manufacturing facilities, plant expansions, and capacity enhancement projects.
• Develop and manage project schedules, budgets, timelines, and resource plans using tools such as Primavera or MS Project .
• Coordinate with consultants, architects, and EPC contractors for basic and detailed engineering, procurement, and construction activities.
• Drive installation, commissioning, and qualification (IQ/OQ/PQ) of process, utility, and ancillary systems.
• Ensure on-time delivery of projects within approved budgets and scope.

2. Engineering & Technical Oversight

• Review and approve Process Flow Diagrams (PFDs) , Piping & Instrumentation Diagrams (P&IDs) , equipment data sheets, and layout drawings.
• Ensure engineering design adheres to cGMP , USFDA , EMA , MHRA , and WHO standards.
• Support technology transfer , process scale-up , and equipment selection in coordination with R&D and Manufacturing teams.
• Provide technical leadership in areas such as utilities (WFI, clean steam, HVAC, chillers, compressed air) and cleanroom design .

3. Cross-Functional Coordination

• Collaborate closely with internal teams including Production, Quality Assurance, Quality Control, Regulatory Affairs, EHS, and Procurement for smooth execution.
• Work with Finance and Procurement for cost estimation, vendor selection, contract negotiation, and budget tracking.
• Lead site-based project teams , ensuring effective communication, accountability, and goal alignment.
• Build strong relationships with external partners, consultants, and suppliers to ensure best-in-class project delivery.

4. Compliance, Quality & Safety

• Ensure strict adherence to EHS (Environment, Health & Safety) and Quality Management standards throughout project execution.
• Conduct Hazard and Operability Studies (HAZOP) , risk assessments, and implement mitigation strategies.
• Ensure all activities comply with statutory, local, and international regulatory requirements.
• Support readiness for regulatory audits and inspections related to project and facility setup.

5. Reporting & Documentation

• Prepare comprehensive project reports , including progress updates, risk analysis, and deviation reports, for senior management.
• Maintain accurate documentation as per GMP and project management protocols.
• Track project performance against defined KPIs and milestones , recommending corrective actions as needed.
• Present updates in management review meetings and provide visibility into project health and financial status.
  

Qualifications & Experience

Education:

• B.E./B.Tech/M.Tech in Chemical Engineering

Experience:

• Minimum 15+ years of experience in API or bulk drug project management , preferably with leading pharmaceutical companies.
• Proven experience in executing Greenfield and Brownfield projects from concept to commissioning.
• Exposure to multi-location projects (India and/or international sites).
• Strong understanding of GMP facility design , process equipment , utilities , and HVAC systems .
• Familiarity with international regulatory guidelines – USFDA, EMA, MHRA, WHO.
• Proficiency in project management tools such as Primavera, MS Project , and AutoCAD .
  

Key Competencies & Skills

• Strong leadership and people management skills; ability to lead cross-functional teams.
• Excellent communication, negotiation, and stakeholder management capabilities.
• Strategic thinker with a hands-on execution approach .
• Strong analytical, problem-solving, and decision-making abilities.
• Demonstrated ability to manage budgets, timelines, and multiple priorities under pressure.
• Commitment to quality, safety, and regulatory compliance .
• Willingness to travel extensively (domestic and international) based on project needs.
  

Key Performance Indicators (KPIs)

• Timely completion of projects within approved budget and scope.
• Compliance with regulatory, safety, and quality standards.
• Effective vendor and contractor management.
• Achievement of project milestones and financial targets.
• Stakeholder satisfaction and cross-functional collaboration effectiveness.