Head of Quality CDMO

Terumo Europe; Leverkusen; Vor Ort; EUR 80.000 - 110.000; Vollzeit

Zusammenfassung

A global medical technology company in Leverkusen is seeking an experienced Head of Quality CDMO to lead their quality strategy. The role requires 10+ years in quality within a CDMO environment and strong managerial experience, ensuring compliance and promoting a culture of excellence. This is a full-time position offering competitive compensation and professional development opportunities.

Leistungen

Competitive compensation package

Continuous learning and professional development opportunities

International exposure

Qualifikationen

• 10+ years in Quality within a CDMO sterile manufacturing environment.
• 5+ years of managerial experience interpreting strategy and delivering results.

Aufgaben

• Develop and implement the quality strategy in alignment with corporate goals.
• Lead internal audit planning, implementation, and reporting.
• Ensure operations meet regulatory and internal policy requirements.
• Represent the company’s Quality function in customer meetings.
• Design and evolve the quality organization structure.
• Set, track, and report on team KPIs and objectives.

Kenntnisse

Stakeholder management

Quality assurance (QA)

Regulatory compliance

Strategic thinking

Communication skills (German, English)

Ausbildung

University Degree; Master’s Degree preferred

Jobbeschreibung

Overview

Join to apply for the Head of Quality CDMO role at Terumo Europe.

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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