Quality Site Head
Cologne, Germany
The Quality Site Head serves as the primary authority for Quality and Regulatory expertise at the site, providing strategic leadership and oversight of Quality Assurance and Quality Control functions. This role requires a dynamic leader who can foster collaboration, strengthen morale, cultivate a strong quality culture, and drive innovation to build a world‑class organization.
The ideal candidate thrives in a matrix environment, effectively leads cross‑functional and global initiatives, and can define a clear vision for the future—then translate that vision into actionable plans and measurable outcomes. As a highly visible member of the senior site leadership team, you will be predominantly onsite, ensuring close engagement with operations and stakeholders.
Our Cologne site operates within the cell and gene therapy market, supporting broader manufacturing activities and playing a pioneering role in automated cell therapy manufacturing.
What you will do
- Develop and execute the site’s Quality strategy in alignment with the company’s global Quality and business objectives, ensuring strong customer focus.
- Drive continuous improvement initiatives to enhance Quality systems, operational efficiency, productivity, and cost control.
- Establish, implement, and oversee Quality programs, policies, and procedures to ensure compliance with GxP, ISO standards, corporate requirements, and applicable regulatory guidelines.
- Define, monitor, and drive compliance with critical metrics at departmental, site, and global levels.
- Serve as the external representative on product quality matters, customer satisfaction, and regulatory interactions. Lead all customer and regulatory audits, inspections, and associated corrective and preventive action programs.
- Develop and implement robust training and development plans to strengthen the competence, integrity, and effectiveness of the Quality organization.
- Build and maintain strong relationships with customers and regulatory authorities, representing the company on site‑specific Quality and GxP compliance matters.
What you will bring
- Master’s degree (or equivalent experience) in Life Sciences, Engineering, Quality Management, or a related scientific discipline.
- Extensive leadership experience in Quality Assurance, Quality Control, and Regulatory Compliance.
- Significant experience in GMP‑regulated manufacturing environments, with products overseen by European and U.S. health authorities, and a strong background in Quality Management.
- Experience implementing lean manufacturing principles.
- Demonstrated success leading high‑performing teams, including experience remediating compliance challenges and driving sustainable improvements.
- Proven ability to plan strategically and manage budgets at a senior leadership level.
- Track record of fostering a culture of empowerment, accountability, curiosity, and strong problem‑solving capability.
- Business proficiency in both English and German.
