Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. 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 & Development
Our 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).
Ensure 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.
Acting 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).
Managing the Suspected Serious Breaches
Supporting the preparation, management and follow-up of GCP inspections from Regulatory Authorities.
Managing the GCP deviations.
Writing the SOPs and work

R&D QA GCP Manager

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