Location – Munich, Germany
Role – Senior Manager of Quality Management Systems
Company Overview: Our client is a cutting-edge biotechnology organisation dedicated to advancing clinical-stage pipeline to have a true impact on the patinets lives. Committed to delivering innovative solutions, they are now in search of an experienced Senior Manager to ensure the highest standards of quality and compliance across their operations.
Key Responsibilities – As the Senior Manager of Quality Management Systems, you will play a pivotal role in establishing and maintaining a robust quality management system. Your responsibilities will include:
- Leading the design, development, and implementation of the quality management system to meet regulatory requirements and industry standards.
- Conducting thorough supplier audits to assess and ensure compliance with quality standards and regulatory expectations.
- Collaborating cross-functionally to identify and implement continuous improvement initiatives within the quality management system.
- Serving as a key liaison with regulatory agencies and participating in regulatory inspections as needed.
- Providing leadership and mentorship to the quality management team, fostering a culture of excellence and accountability.
- Bachelor’s or Master’s degree in a relevant scientific or engineering discipline.
- Minimum of 5 years of experience in quality management within the biotechnology or pharmaceutical industry.
- Proven expertise in the development and implementation of quality management systems.
- Extensive experience in conducting supplier audits and managing supplier relationships.
- Strong knowledge of relevant regulatory requirements and standards (e.g., FDA, EMA, German Regulations).
- Excellent leadership, communication, and interpersonal skills.