Manager (w/m/d) Quality System & International Change Control

at  B Braun Melsungen AG

Within the Hospital Care division, we are looking for a Manager (f/m/d) Quality System & International Change Control for Quality Management, QM Operations - Center of Excellence Pharmaceuticals, for our group headquarters at the Melsungen site at the earliest possible date.
Internal and external factors are constantly driving change. Change control is an essential element for their evaluation and implementation in order to ensure product quality as well as GMP and regulatory compliance.
Quality Management (QM) Operations links the quality assurance units of the B. Braun pharmaceutical plants worldwide, sets modern standards for our Pharmaceutical Quality System and applies these globally in cooperation with the manufacturing sites.

• You coordinate the evaluation and approval of cross-site change controls and external change notifications
• You maintain close and active collaboration with interdisciplinary and international teams and partners such as Quality Assurance, Regulatory Affairs, Competence and Production Centers, Global Quality Control, Product Owners, Marketing and Development
• You will also be responsible for coordinating and planning the phases and necessary content of the change projects, taking into account quality risk management, GMP and regulatory compliance
• You will also create activity and time schedules in the change control system and monitor the phases
• You will further develop the change control process for the effective and efficient management of changes in the area of pharmaceutical products
• Another responsibility of yours will be providing advice and carrying out specific training on change controls
• Furthermore, you will provide support in the preparation and monitoring of official inspections
• Finally, you will occasionally be responsible for reviewing, approving and monitoring international CAPAs.