Clinical Quality Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7etk9h

This role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose is to work with global or regional Quality Management teams, functional teams, and other stakeholders to define the global Quality Plan, carry out and adopt the plan according to the scope of assignment, and assist staff in improving compliance with ICH, GCP, SOPs, KPIs, applicable regulatory requirements, and guidelines. This role provides advice and supports clinical staff and other stakeholders with regard to quality control, risk management, and corrective/preventive actions.
Conduct country and site-level compliance oversight using a risk-based approach.
Identify compliance risks, conduct site assessments, and manage CAPAs.
Support inspections and audits while serving as the local GCP expert.
Drive inspection readiness and compliance at the country level.
Adopt and implement the global Quality Management Plan within the scope of the assignment,



including planning and executing Quality Management activities, risk identification and assessment through data review and quality control processes, and supporting risk mitigation and corrective/preventive actions guidance for improvement.
Cooperate closely with relevant business and other stakeholders to maintain focus on quality in project delivery.
Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program; monitor implementation and delivery.
Provide advice and support to teams on all aspects of Good Clinical Practice (GCP) compliance.
Work with teams to manage non-compliance and quality issues; support planning of corrective/preventive actions as applicable according to SOPs.
Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
Work closely with Quality Assurance and assigned business staff in case of

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7etk9h