Gcp/gvp Quality and Compliance Manager - Roma, Italia - Meditrial Europe Ltd.

Meditrial Europe Ltd.

Azienda verificata

Roma, Italia

3 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

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".

GCP/GVP 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.
Develop and prioritize an audit strategy for all programs
Plan and lead GVP and GCP compliance audits (US and international), including clinical investigator sites, contract clinical laboratories and all clients to determine compliance status and identify compliance risks
Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented
Partner with Clinical Development, Clinical Operations, Nonclinical and Regulatory Affairs stakeholders regarding compliance issues and provide compliance guidance to audited parties to encourage process improvement, serve as an expert in the interpretation of GCP and GVP regulatory requirements and expectations
Manage QA reviews of project-related of essential clinical study documents
Manage regulatory authority inspections and the coordination of responses to resolve inspection findings, if any
Lead GCP/GVP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies
Develop and implement standards, policies, and procedures for GCP/GVP regulatory compliance
Report and escalate compliance issues to management, including requests for directed audits
Participate in quality and compliance improvement initiatives within and outside of Clinical Development/Clinical Operations departments
Provide guidance, interpretation and information on GCP and GVP regulations, standards and quality systems
Prepare internal QA reports, provide input for external partners/ clients

Preferred Experiences & Requirements
BS/BA degree in scientific discipline from an accredited college or university or equivalent experience. Advanced degree preferred
8 to 10 years of relevant pharmaceutical industry experience, with a minimum of 5 years of GCP compliance, preferably in an FDA regulated environment
Experience in the large pharmaceutical industry and start up environment preferred
Experience in planning and conducting GCP and GVP audits
Experience with regulatory inspections and inspection readiness (EU experience is a plus)
Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs)
Experience reviewing and auditing study-related documentation (e.g, nonclinical and clinical study reports, Investigator's Brochures)
Strong team player with a demonstrated track record of success in a cross-functional team and fast-moving environment.
Excellent organizational, computing and oral/written communication skills
Ability to influence and negotiate effective solutions
Strong critical thinking and decision-making skills
Ability to travel up to 40%

Personal skills
Ability to communicate, problem solve and work effectively in an international team
Innovative and self-motivated
Good organization skills and ability to prioritize goals and responsibilities
Ability to negotiate