Manager of Quality In-Process

Responsibilities

• Manage an In-Process Quality team of 10 people working in cleanroom environments
• Oversee deviation management, including internal non-conformity approvals and CAPA processes
• Ensure site compliance with ISO standards, GMP requirements, and Quality Management System (QMS) documents
• Manage quality documentation and approve manufacturing process-related documents
• Lead and participate in internal, client, and notified body audits
• Organize and monitor quality training and personnel qualifications
• Manage change control processes, including validation of change requests and impact analysis
• Participate in product transfer projects and lead FMEA/DFMEA preparations

Requirements

• Engineering degree
• Minimum of 5 years of professional experience in a similar manufacturing or quality environment
• Mastery of quality practices and safety procedures
• Strong knowledge of regulatory requirements
• Proven leadership and interpersonal skills
• Proficiency in English (minimum B1 level)
• Strong analytical, organizational, and planning skills
• Proficiency with IT tools

About the Company

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds who want to contribute to this goal and advance their careers in a dynamic global environment.