Quality assurance manager biomedicine (m f
Miltenyi biotec b.v. & co. kg
- Bergisch Gladbach
stellenbeschreibung
Job Description Your role 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. Your profile * You hold an academic degree and have gained relevant job experience in GCP and Quality Management. * Your experience includes providing quality oversight for the risk-based design, conduct and oversight of clinical trials as well as audit experience. * You bring along a deep knowledge of quality assurance principles including FDA, ICH and GCP regulations and guidance and you are well trained in quality control of production documentation and release of ATMPs (QP function). * You have excellent organizational skills, work independently and in a structured way. * You have a high degree of process affinity and self-responsibility and you are strong in communicating in English (oral and written). What we offer * A modern workplace and exciting opportunities in the development of technologies with a secure future * Cross-border intercultural cooperation and short communication channels * A collegial corporate culture and flexible working hours enable time management on your own terms * Personalized employee development program:specialist and personal training courses provided by our own training academy * Diverse corporate benefits with regard to employee health, sport, and staff events Contact us If you have the skills and qualifications for this position, please use the link to send us your details (application letter, curriculum vitae, references and certificates). Please give us some idea of when you can start and the kind of salary you are looking for. Your contact Nadia Boutari +49
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