R&D QA GCP Manager

Experteer Overview  In this role you drive GCP compliance within clinical development, acting as a QA reference for project teams. You’ll implement and maintain the quality system in GCP areas and support study design, execution, and reporting. You will review key clinical documents, manage breaches and deviations, and support regulatory inspections. You’ll also author SOPs and ensure alignment with current regulations, collaborating with R&D and clinical teams to sustain high-quality, compliant trials.
Retribuzione / Benefits   Act as QA GCP reference for clinical project teams across organic and inorganic growth
Implement and maintain the GCP quality system
Review clinical study documentation (protocols, amendments, patient information sheets, informed consent, CSR)
Manage Suspected Serious Breaches and GCP deviations
Support preparation and follow-up of GCP inspections by Regulatory Authorities
Manage GCP deviations and non-conformances
Create SOPs and working instructions for R&D QA GCP activities
Review SOPs for clinical studies to ensure regulatory compliance
Responsabilità   At least 3 years’ experience as clinical QA in pharmaceutical companies or clinical CROs OR at least 3 years’ experience in clinical studies as CRA or Project Manager in pharma or CROs
Scientific degree, Pharmacist or Life Sciences
Deep English knowledge (spoken and written)
Knowledge of GCP regulations
Proficiency with common computer tools (e.g., Office)
Requisiti fondamentali   comprehensive healthcare programs
work-life balance initiatives
relocation support
flexible working arrangementsremote work options
tax assistance services for foreign colleagues

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