R&D QA GCP Manager

15 ago - Emilia-Romagna
Cv-Library

About usChiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy.

Continui a leggere per comprendere appieno cosa richiede questo lavoro in termini di competenze ed esperienza. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose.

As a Agevolazioni Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.We believe our differences make us stronger.

Chiesi Research & DevelopmentOur R&D; team represents a fundamental asset for the business.

It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D; project and portfolio management.





Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).Who we are looking forThis is what you will doEnsure the GCP compliance within the project teams, acting as QA reference person in the clinical project teams.Ensure the implementation and maintenance of the quality system in the GCP areas.You will be responsible forActing as QA GCP reference person in the clinical project teams, both related to organic and inorganic growth, providing QA inputs and supporting the clinical study teams in the design, execution and reporting of clinical studies.Reviewing the documents related to clinical studies (protocol/amendment, patient information sheet/Informed consent form, CTS label, CTS instruction for use, CSR).Mana

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