Sr Capital Projects Manager

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

The Senior Capital Projects Manager leads major capital investment projects (€20M+) and drives the development and continuous improvement of HAL's Project Management Office (PMO). The position combines project leadership, governance, and portfolio oversight to ensure successful delivery of strategic projects and sustainable project management practices across the organization. The Senior Capital Projects Manager works closely with Manufacturing, Engineering, Quality, Regulatory Affairs, R&D, Supply Chain, Finance, and external partners to deliver business objectives and strengthen project management capabilities across HAL.

Relocation support may be available for exceptional international candidates.

Project leadership

• 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.

PMO & Governance

• Establish, maintain, and continuously improve HAL's PMO, including governance, project standards, tools, and reporting.
• Drive portfolio management, project prioritization, resource planning, and executive decision-making processes.
• Develop KPI dashboards and portfolio reports and facilitate governance and project review meetings.
• Train and mentor HAL employees, standardize project management practices, and promote PMO best practices across the organization.

Stakeholder Management

• Build and manage strong relationships with senior leaders, cross-functional teams, suppliers, contractors, and other key stakeholders.
• Lead cross-functional project teams including Manufacturing, Engineering, Quality, Supply Chain, Technical Services, Validation, Regulatory Affairs, and Finance.
• Align project execution with business objectives and serve as a trusted advisor to project teams and stakeholders.
• Facilitate SteerCo and governance meetings to support effective project oversight and executive decision-making.
• Communicate project status, progress, risks, mitigation plans, and recommendations clearly to all levels of the organization.
• Manage external partners, including equipment suppliers, engineering firms & consultants.

Risk & Compliance Management

• Identify, assess, and manage project risks and opportunities, ensuring effective mitigation and escalation where required.
• Oversee project budgets, forecasts, and financial performance.
• Ensure effective change control and scope management practices.
• Ensure all projects comply with GMP, EHS, quality, validation, and regulatory requirements.
• Ensure successful completion of FAT, SAT, Commissioning, Qualification, and Operational Readiness activities.
• Lead initiatives to improve project delivery capabilities and organizational maturity.
• Implement lessons learned and best practices across the portfolio.
• Support digital transformation and implementation of PMO tools and reporting solutions.
• Mentor and coach project managers and project team members.

You have

• 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, including Computer System Validation (CSV), Annex 1 requirements, and sterile injectable manufacturing processes.
• Demonstrated ability to drive quality and compliance initiatives in pharmaceutical operations; experience with TrackWise and other quality management platforms is considered a strong advantage.
• Experience managing senior stakeholders, governance committees, engineering partners, OEMs, EPCM firms, and contractors.
• Proficient in project and portfolio management tools (e.g., MS Project, Smartsheet); PMP/Prince 2 certification required.
• Fluent in English; Dutch is an advantage.

Who are we looking for?

You are a hands-on project leader who combines technical knowledge, quality awareness and strong stakeholder management skills. You thrive in complex regulated environments and are comfortable leading multidisciplinary teams through challenging CAPEX projects while maintaining compliance, quality and business focus.

Our offer

• You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
• A culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
• You will be working in our dynamic headquarters in Leiden, where we work on the full project pipeline from development to commercial production.
• Being part of a company that is geared towards helping people live happier and healthier lives.
• A competitive salary that matches your responsibilities and experience.
• 30 leave days.
• Company contribution to a pension package and health insurance.

HAL Allergy, for those who seek pharmaceutical innovation

HAL Allergy is one of the European top players in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We focus on the development and manufacturing of modified allergen extracts for the therapeutic and diagnostic purposes of respiratory and food allergies. With all our activities the patient's well-being is always top of mind. At Hall Allergy we foster open discussions, an entrepreneurial spirit and close collaborations within the teams and with our international colleagues summing up to more than 300 highly specialized people across various positions. If you too would like to become a part of an innovative and challenging pharmaceutical manufacturer, then this is your perfect opportunity!

HAL Allergy is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HAL Allergy is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.