At Miltenyi Biotec, 2500 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases. In the newly created Miltenyi Biomedicine GmbH, a daughter company of Miltenyi Biotec focusing on pharma, we bundle our activities for the development and marketing of cell therapeutics.
- The overall goal of this newly created function is to develop, maintain and continuously improve an Quality Management System for medicinal products (especially ATMPs) in Biomedicine embedded in MasterControl and based on existing quality management standards complying with GCP and regulations in Europe, USA and APAC.
- You will report goals, measures and improvements related to the quality system and customer satisfaction to the top management of Miltenyi Biomedicine. Also, you will ensure that all employees understand our customers’ requirements and their own contribution.
- Your task will not only include the development and care for processes, the conduction of deviation, change and KPI management together with departments in Biomedicine, but your task will also be to audit, inspect, prepare, conduct and follow-up. You will be responsible to develop and continuously improve the vendor management (system) and trainings (e.g. for Master Control).
- You will provide support, guidance and quality oversight for clinical studies requiring a focus on compliance with Good Clinical Practice (GCP) regulations and guidance documents. Therefore you will develop a clinical quality system/procedure and quality assurance plans and will implement actions necessary. You will review regulatory and clinical documents for accuracy and internal consistency as it applies to quality (e.g. protocols, informed consent forms, clinical study reports). In addition, you will ensure inspection readiness in collaboration with Clinical Operations, Regulatory Affairs, vendors and other stakeholders.
- You will support risk management plans for clinical activities and supply – if needed - risk mitigation strategies and plan, conduct and supervise internal/external audits together with BM departments/QA.