Head of Quality CDMO

Overview

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We are looking for an experienced Head of Quality to lead the development and execution of our Quality strategy within a dynamic Contract Development and Manufacturing Organization (CDMO) environment. This role is pivotal in ensuring the delivery of safe, compliant, and high-quality products to our global customers. You will be a leader, collaborating across departments and influencing key business processes, while representing our company in high-stakes customer and regulatory settings. This position reports to the Vice-President Quality and Regulatory of Terumo Europe, and will work closely with the site leader of our plant in Nordrhein-Westfalen.

Job Responsibilities

• Strategic Leadership: Develop and implement the quality strategy in alignment with corporate goals. Anticipate challenges, identify improvement opportunities, and ensure integration with broader business objectives.
• Quality Governance: Lead internal audit planning, implementation, and reporting to ensure continuous compliance and improvement.
• Regulatory Compliance: Ensure all operations meet external regulatory and internal policy requirements to minimize business risk.
• Stakeholder Engagement: Represent the company’s Quality function in customer meetings, promoting our quality standards and capabilities.
• Organizational Development: Design and evolve the quality organization structure. Identify and develop key capabilities across the team through mentoring and development planning.
• Performance Management: Set, track, and report on team KPIs and objectives. Hold team members accountable and take corrective actions as needed.
• Continuous Improvement: Promote a culture of quality excellence, leading initiatives to enhance quality systems and performance at the facility level.

Profile description

• Education: University Degree; Master’s Degree preferred

• Experience:
• 10+ years in Quality within a CDMO sterile manufacturing environment.
• 5+ years of managerial experience interpreting strategy and delivering results in medium-to-long-term horizons

• Expertise:
• In-depth knowledge of quality and regulatory requirements in pharmaceutical/biotech CDMO operations. Both QA and QC are important, with an emphasis on QA.
• Proven ability to manage complex systems and lead cross-functional teams.
• Strategic thinker with the ability to connect long-term vision to actionable plans.
• Excellent communication and stakeholder management skills, including cross-cultural sensitivity.
• Strong focus on accountability, continuous improvement, and collaborative leadership.
• Able to have professional conversations in German and English

We offer

• A key leadership role in a brand new CDMO organization, bringing our CDMO experience from Japan to Europe.
• International exposure: An opportunity to collaborate with the EMEA and Global Quality team.
• A dynamic work environment where your expertise will directly impact our business success
• You will be coached by Koen Verhaert, who will show you the in\'s and out about working within Terumo Europe and our Global Quality organisation.
• Competitive compensation package and benefits.
• Continuous learning and professional development opportunities.

Seniority level

• Director

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Medical Equipment Manufacturing

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