Head of Quality CDMO

Head of Quality CDMO (f/m/d) At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations. Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for Department Info Pharmaceutical Solutions Division (PSD) develops patient-oriented parenteral delivery solutions for therapeutic performance and safety. Globally trusted for quality and precision, Pharmaceutical Solutions Division offers pharmaceutical and medical device manufacturers around the world comprehensive product design and development services and solutions. We have decades of experience collaborating with pharmaceutical companies from the earliest phases of drug development to product commercialization to optimize critical aspects of parenteral drug delivery. For our new Contract Development and Manufacturing Plant in Nordrhein-Westfalen, we are looking a Head of Quality Job Summary 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 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. Contact Person Jan Swinnen, Talent Acquisition Lead EMEAFirst interview is done by our headhunter - Vector Talent Working at Terumo means advancing healthcare with heart. Here, you are empowered to grow your own way, inspired to create to innovate, and supported as we get there together. Join us in shaping a healthier future for our patients, society, and each other.