Clinical Quality Assurance Manager Milano

Clinical Quality Assurance Manager
Milano
Lombardia, Milano

Adecco Italia Spa - Life Science is looking for a Clinical Quality Assurance Manager in preparation for the expansion of clinical activities, planning to strengthen the office of clinical quality assurance.

The position will be responsible for assessing compliance with SOPs, GxP, European regulations, local regulations and guidelines, and clinical study protocols.

This position will collaborate with other functions in the Clinical Department.

Responsibilities:Maintain GCP/ICH compliant systems and processes to ensure the quality of work and clinical trials conducted in Europe and the US. Write and/or review clinical SOPs and support continuous process improvements. Manage staff training on company procedures, GCP regulations, and documentation systems. Qualify CROs and other vendors related to clinical activities. Perform documentation control in the TMF and quality reviews of essential clinical trial documents. Conduct routine internal system and TMF audits and checks throughout the trial/program lifecycle to ensure compliance with internal procedures and regulatory guidelines. Report significant clinical quality deficiencies and/or risks to upper management and actively participate in resolving issues. Perform clinical site GCP auditing activities to ensure studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations. Lead the preparation of the company and clinical sites for customer audits and regulatory GCP inspections.

Participate as a Subject Matter Expert during regulatory GCP inspections. Ideal Candidate Requirements:Strong scientific background (preferably Master/PhD in Biology, Biotechnology, Life Sciences, etc.

). Ideally 3-5 years of experience in Clinical Quality oversight (clinical QA experience in the pharmaceutical industry required). Complete understanding and application of principles, concepts, and practices of clinical research procedures. High level of English proficiency, both written and spoken. High attention to detail. Ability to work independently, prioritize tasks, and coordinate other team members. Excellent interpersonal skills, flexibility in changing tasks and priorities, and motivation for new challenges. Expected contract type: permanent.

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