Senior Project Manager – External Manufacturing Capital Projects

About the role

The Senior Project Manager will lead large‑scale capital investment projects executed by external manufacturing partners (CMOs) for a global pharmaceutical diagnostics organization. The role oversees the full project lifecycle in a GMP‑regulated environment, ensuring safety, quality, schedule, and budget compliance.

Key responsibilities

• Act as the company representative for CMO‑executed capital investments, managing EPCM partners.
• Lead projects from concept, feasibility, and business case through design, construction, commissioning, qualification, and handover.
• Develop and maintain execution plans, schedules, budgets, cost forecasts, governance, and risk management processes.
• Ensure compliance with cGMP, GxP, EHS, Lean, and corporate engineering standards.
• Coordinate multidisciplinary teams across engineering, quality, validation, operations, procurement, and external contractors.
• Manage contractor and supplier performance, including selection, contract negotiations, change control, and oversight.
• Drive cost management, estimating, forecasting, and risk mitigation to meet investment and cash‑flow targets.
• Facilitate stage‑gate reviews and support regulatory inspections, audits, and submissions.

Required profile

• Proven experience delivering medium‑ to large‑scale capital projects in pharmaceutical GMP manufacturing environments.
• Strong leadership of cross‑functional teams and ability to work with external partners.
• Deep knowledge of cGMP, GxP, EHS, and Lean engineering standards.
• Excellent risk, budget, and schedule management capabilities.

Required skills

• Project lifecycle management (concept to handover)
• GMP / cGMP compliance
• EPCM partner coordination
• Risk management and mitigation
• Budgeting and cost forecasting
• Schedule development and control
• Contract negotiation and supplier oversight
• Regulatory and quality interface