Senior Quality and Compliance Manager Roma
Meditrial is a full-service digital research organization with a foundation in clinical trial research, education, regulatory and market access. Meditrial has been leading the medical tech industry by delivering unparalleled outcomes for innovators. Our successful track record supporting medical device and biotechnology companies in all phases of clinical development puts us in a prime position to seize the opportunity to emerge as a leader in digital technology with the promise that it will enhance and alleviate the clinical trial and participant burden. Through our work, the patient and innovator are empowered with data and insights across the lifecycle of product development and market penetration changing the paradigm of care towards understanding and value. Meditrial, as a recognized leader in the medtech field participates in the development of global standards, policies and regulations. We have the ability to transcend the current landscape with “smart” technology enabled data collection tools and insights that are being regulated by the medical device “rule book”.
Senior Quality and Compliance Manager:
Meditrial is looking for an experienced professional capable of managing Quality and Compliance activities for GCP/GVP, maintenance of ISO 9001:2015, ISO 13485:2016, ISO 27001:2013 certifications and to provide compliance expertise together with the clinical department to ensure GCP and GVP compliance across all Meditrial projects. Additionally, the position will be responsible for implementing clinical compliance plans to include external GCP and GVP audits of clients, suppliers, and investigator sites, as well as internal audit of clinical processes and procedures. The role will report to the Chief Medical Officer and Global Head of Regulatory and Quality.
Responsibilities
Formulate GCP compliance strategy and provide advice for all programs within Meditrial
Assess GCP and GVP compliance risk areas and develop and implement risk mitigation measures.
meditrial is a full-service digital research organization with a foundation in clinical trial research, education, regulatory and market access, meditrial has been leading the medical tech industry by delivering unparalleled outcomes for innovators, our successful track record supporting medical device and biotechnology companies in all phases of clinical development puts us in a prime position to seize the opportunity to emerge as a leader in digital technology with the promise that it will enhance and alleviate the clinical trial and participant burden, through our work, the patient and innovator are empowered with data and insights across the lifecycle of product development and market penetration changing the paradigm of care towards understanding and value
responsabilità: BS/BA degree in scientific discipline from an accredited college or university or equivalent experience. Advanced degree preferred
Requisiti: ability to travel up to 40%
Posizione di lavoro: quality manager
