ph3Experteer Overview /h3pIn 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 RD and clinical teams to sustain high-quality, compliant trials. /ph3Retribuzione / Benefits /h3ulliAct as QA GCP reference for clinical project teams across organic and inorganic growth /liliImplement and maintain the GCP quality system /liliReview clinical study documentation (protocols, amendments, patient information sheets, informed consent, CSR)



/liliManage Suspected Serious Breaches and GCP deviations /liliSupport preparation and follow-up of GCP inspections by Regulatory Authorities /liliManage GCP deviations and non-conformances /liliCreate SOPs and working instructions for RD QA GCP activities /liliReview SOPs for clinical studies to ensure regulatory compliance /li /ulh3Responsabilità /h3ulliAt 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 /liliScientific degree, Pharmacist or Life Sciences /liliDeep English knowledge (spoken and written) /liliKnowledge of GCP regulations /liliProficiency with common computer tools (e.g., Office) /li /ulh3Requisiti fondamentali /h3ullicomprehensive healthcare programs /liliwork-life balance initiatives /lilirelocation support /liliflexible working arrangementsremote work options /lilitax assistance services for foreign colleagues /li /ul /p #J-18808-Ljbffr

📌 R&D QA GCP Manager (Parma)
🏢 Experteer Italy
📍 Parma