General Manager - Projects

Job Purpose: To oversee the end-to-end planning, execution, and delivery of complex engineering and construction projects in a biopharmaceutical injectable manufacturing plant. This includes managing civil, clean utilities, grey utilities, and other critical infrastructure to ensure timely and cost-effective project completion while adhering to industry standards, regulatory requirements, and company objectives.

Role & responsibilities:

• Develop comprehensive project plans, covering scope, budget, and timelines.
• Oversee civil construction activities ensuring safety, quality, and adherence to standards.
• Manage clean utilities, including WFI, clean steam, HVAC, and compressed air systems.
• Supervise grey utilities, such as power supply, wastewater management, and non-critical utilities.
• Ensure compliance with cGMP, FDA, EMA, and other regulatory guidelines.
  Coordinate with cross-functional teams (QA/QC, engineering, manufacturing, EHS, and procurement) for seamless project execution.
• Lead and mentor project teams, ensuring high performance and alignment with objectives.
• Identify risks, implement mitigation strategies, and resolve project-related challenges.
• Monitor and control budgets, resources, and expenditures to ensure cost-effective project delivery.
• Provide regular project updates and reports to senior management.

Accountabilities and Responsibilities:

1. Project Planning and Execution:

• Develop comprehensive project plans, including scope, budgets, schedules, and resource allocation.
• Lead and manage multiple projects simultaneously, ensuring alignment with organizational goals and timelines.
• Ensure proper feasibility studies, design, and cost estimations are conducted for projects.

2. Technical Oversight:

• Oversee civil construction activities, ensuring compliance with design, safety, and quality standards.
• Manage clean utilities such as water for injection (WFI), purified water, clean steam, compressed air, and HVAC systems in adherence to GMP guidelines.
• Supervise grey utilities, including power, wastewater, and other non-critical utilities, ensuring operational efficiency and reliability.

3. Regulatory Compliance:

• Ensure all projects meet regulatory requirements, including FDA, EMA, and local government standards.
• Liaise with quality assurance and validation teams to ensure projects adhere to cGMP guidelines and are audit-ready.

4. Team Leadership and Coordination:

• Build, lead, and mentor a high-performing project management team.
• Coordinate with cross-functional departments, including engineering, manufacturing, QA/QC, procurement, and EHS teams.
• Manage relationships with contractors, consultants, and vendors to ensure efficient project delivery.

5. Risk Management and Reporting:

• Identify potential risks and implement mitigation strategies to avoid project delays or cost overruns.
• Prepare and present regular status reports to senior management, highlighting progress, challenges, and solutions.

6. Budget Management:

• Monitor and control project budgets, ensuring efficient use of resources.
• Review and approve project expenditures and ensure cost optimization throughout project lifecycles.

Competencies:

• Strong project management skills, including planning, execution, budgeting and resource management.
• In-depth knowledge of cGMP, regulatory standards, and cleanroom classifications.
• Excellent leadership, decision-making, and problem-solving abilities.
• Proficiency in project management tools (e.g., MS Project, Primavera).
• Exceptional communication and interpersonal skills to work effectively with internal and external stakeholders.
• Stakeholder management skills.
• Ability to handle high-pressure environments and deliver results on time.

Preferred candidate profile:

• Minimum 15 years of project management experience, with at least 5 years in a biopharmaceutical injectable manufacturing environment.
• Hands-on experience with civil, clean utilities (WFI, clean steam, HVAC), and grey utilities (power, wastewater).
• Bachelors degree in Engineering (Civil, Mechanical, or Electrical).
  Masters degree or PMP/PRINCE2 certification is a plus.