R&D Quality Manager (m/f/d)

With over 15 years of experience in the classic pharmaceutical industry, biotechnology, chemistry and medical technology, we know the key contact persons who write out demanding tasks with potential. The high demand for personnel opens up exciting opportunities for dedicated professionals and managers to develop professionally and work on their own careers. As a specialized staff consultancy with an international network, we offer you decisive advantages - and this is completely free of charge for you. Register and benefit from interesting and matching positions and projects.

Support for initiatives to maintain or improve the quality performance and compliance of Novartis PVC activities, including case management, medical security, risk management, reporting to health authorities, PV IT systems and device monitoring Supporting initiatives with a focus on quality, process and compliance improvements, through close cooperation with business partners identify opportunities and develop strategies to simplify processes and improve quality - while ensuring compliance with regulatory requirements Providing quality support for transition and integration activities for PV and DV systems resulting from mergers, acquisitions and/or divestitures Providing quality support for PS&PV and other groups/partners involved in PV and DV activities support in identifying problems and in Cause Analysis; Approval of investigation reports Support for inspections by health authorities, including measures for the readiness to inspection, implementation and follow-up guidance in the development of robust and sustainable corrective and preventive measures (CAPA) in cooperation with the groups responsible for PV and DV activities Monitoring CAPA’s status to ensure that problems are properly addressed, completed and documented Ensure that quality and compliance problems are communicated to the relevant management in a timely manner support initiatives to address compliance issues; assessment of the effectiveness of measures; ongoing project support and governance Supporting activities for effective quality monitoring, control and support of global PV-operative service providers Promoting quality awareness and improvement in service providers

experience in PV/PV quality or in the pharmaceutical industry and/or in a health authority; Experience in device monitoring is advantageous Experience with PV audits or inspections and interactions with health authorities is beneficial Experience in maintaining PV and/or device quality management systems is advantageous Ability to manage and evaluate compliance problems with limited supervision; good skills in problem solving, decision making and prioritization Embossed quality orientation knowledge of PV regulations, policies and policies; Knowledge of GCP and Part-11 requirements are advantageous Ability to work across functions and in diverse cultural environments

International company Flexible work Partial remuneration