Senior Capital Projects Leader - Pharma & GMP Excellence

HAL Allergy International; Leiden; Remote; EUR 140,000 - 190,000; Full time

Benefits offered by this job

Relocation assistance

Pension & health insurance

30 leave days

Job summary

HAL Allergy International, based in Leiden, seeks a Senior Capital Projects Manager to lead major CAPEX programs and advance HAL's PMO and governance. You will drive end-to-end project delivery, from business case through commissioning and handover, coordinating manufacturing, engineering, quality, regulatory affairs, and finance.

The role requires a track record in regulated pharma settings, strong GMP/CSV knowledge, and experience with PMO maturation and portfolio governance.

Qualifications

• Bachelor’s or master’s degree in engineering, Pharmaceutical Sciences, Biotechnology, Manufacturing, or related discipline.
• 10+ years of project management experience in pharmaceutical, biotech, medical device, or other highly regulated environments; Six Sigma Black Belt certification is highly preferred.
• Proven track record delivering complex capital projects (€20M+) and leading cross-functional programs.
• Experience establishing and developing PMO capabilities, including portfolio governance and project prioritization.
• Strong knowledge of GMP-regulated environments and pharmaceutical development, manufacturing, and commercialization processes, incl. CSV and Annex 1.

Responsibilities

• Lead end-to-end delivery of major capital investment projects (€20M+) from business case development through execution, commissioning, operational handover, and lifecycle management.
• Develop and maintain integrated project plans, schedules, budgets, resource forecasts, and risk to deliver agreed scope, quality, timeline, and cost objectives.
• Lead cross-functional teams and manage project dependencies, risks, issues, and escalations to achieve key business and project milestones.
• Drive project governance, performance monitoring, and KPI-based reporting, providing clear and timely updates to SteerCo, senior leadership, and key stakeholders.
• Deliver complex manufacturing, facility, and infrastructure projects that support HAL's strategic objectives.
• Establish, maintain, and continuously improve HAL's PMO, including governance, project standards, tools, and reporting.

Skills

Strategic project leadership

Cross-functional collaboration

GMP/regulatory knowledge

Stakeholder management

English fluency

Education

Bachelor’s or Master’s degree in engineering, Pharmaceutical Sciences, Biotechnology, Manufacturing, or related discipline

Six Sigma Black Belt certification

Tools

MS Project

Smartsheet

PMP/Prince2 certification

Job description

HAL Allergy International, based in Leiden, seeks a Senior Capital Projects Manager to lead major CAPEX programs and advance HAL's PMO and governance. You will drive end-to-end project delivery, from business case through commissioning and handover, coordinating manufacturing, engineering, quality, regulatory affairs, and finance.

The role requires a track record in regulated pharma settings, strong GMP/CSV knowledge, and experience with PMO maturation and portfolio governance.