Senior Project Manager

Senior Project Manager – External Manufacturing Capital Projects

Description

A global pharmaceutical diagnostics organization is a market leader in diagnostic imaging agents, including contrast media and molecular imaging products used across cardiology, neurology, and oncology. The business operates a worldwide manufacturing and supply network with multiple GMP-regulated facilities, supporting millions of patient procedures annually.

The organization plays a critical role in advancing precision healthcare through secure supply, innovation, regulatory compliance, and strategic pharmaceutical manufacturing investments.

Role / Reporting LineThis position reports to the Global Head of Capital Projects / Project Management and has a dotted-line reporting relationship to the External Supply Chain Leader, reflecting accountability for capital investments executed through external manufacturing partners (CMOs).

The Senior Project Manager is responsible for the end-to-end delivery of large-scale pharmaceutical capital investment projects within a regulated GMP environment. The role requires leadership of cross-functional teams to deliver complex manufacturing, cleanroom, utilities, and infrastructure projects safely, on schedule, within budget, and in compliance with applicable quality and regulatory requirements.

The role works closely across Engineering, Commissioning & Qualification (C&Q), Quality, EHS, Operations, Supply Chain, Regulatory Affairs, and Finance functions.

Key Responsibilities

• The successful candidate will be accountable for, but not limited to:
• Acting as the company representative for CMO-executed capital investments, leading EPCMV partners and ensuring delivery to corporate safety, GMP, quality, cost, and schedule standards.
• Leading the complete project lifecycle from concept development, feasibility assessment, and business case creation through detailed design, construction, commissioning, qualification, and operational handover.
• Managing medium- and large-scale capital projects within pharmaceutical GMP manufacturing environments.
• Developing and maintaining project execution plans, schedules, budgets, cost forecasts, governance structures, and risk management processes.
• Ensuring compliance with cGMP, GxP, EHS, Lean, and corporate engineering standards throughout project delivery.
• Coordinating multidisciplinary teams across engineering, quality, validation, operations, procurement, and external contractors.
• Managing contractor and supplier performance, including selection, contract negotiations, change control, and ongoing oversight.
• Driving rigorous cost management, estimating, forecasting, and risk mitigation to ensure approved investment and cash-flow objectives are achieved.
• Facilitating project stage-gate reviews to optimize strategies, timelines, resources, and execution plans.
• Partnering with quality and regulatory teams to support inspections, audits, and regulatory submissions as required.
• Promoting a strong safety culture and ensuring safe project execution through best-in-class EHS practices.
• Providing concise, executive-level reporting on project status, risks, mitigation plans, and key decisions.
• Supporting long-term capital planning and manufacturing network strategy initiatives.
• Qualifications & Experience
• Essential
• Bachelor's degree in Engineering (Chemical, Process, Mechanical, or related discipline).15+ years of experience delivering medium to large capital projects within pharmaceutical, biotechnology, or regulated life sciences environments.
• Proven track record of successfully delivering multiple pharmaceutical capital projects, including at least one project or programme exceeding $25 million.
• Strong understanding of cGMP, GxP, pharmaceutical utilities, cleanroom design, and validation principles.
• Demonstrated experience leading large, cross-functional, and multicultural project teams.
• Extensive experience managing EPCMV/EPC contractors and complex global supply chains.
• Advanced expertise in project controls, including scheduling, budgeting, governance, and risk management.
• Strong stakeholder management, communication, and executive reporting skills.

Preferred

Master's degree in Engineering, Project Management, or related field.

Experience supporting small-molecule and/or large-molecule API manufacturing operations.

Professional Project Management certification (PMP, PRINCE2, or equivalent).

Additional Information

Location: Cork, Ireland (hybrid working arrangement with onsite presence required).

International travel required, including occasional weekends and extended assignments.

Expected travel commitment: approximately 20–30% of working time away from home.