Clinical Quality Assurance Manager GCP Specialist

2 settimane fa


Siena, Toscana, Italia Philogen A tempo pieno
Clinical Quality Assurance Manager GCP Specialist Job Description

Philogen S.P.A. is seeking a highly skilled Clinical Quality Assurance Manager GCP Specialist to strengthen its office of clinical quality assurance. This role will be responsible for ensuring compliance with SOPs, GxP, European regulations, local regulations, and clinical study protocols.

Key Responsibilities:
  • Assess and maintain GCP/ICH compliant systems and processes for clinical trials in Europe and the US.
  • Develop and review clinical SOPs, and support continuous process improvements.
  • Manage training of staff on company procedures, GCP regulations, and documentation systems.
  • Qualify CRO and other vendors related to clinical activity.
  • Perform documentation control in the TMF and quality reviews of clinical trial essential documents.
  • Conduct routine internal system and TMF audits to ensure compliance with internal procedures and regulatory guidelines.
  • Report significant clinical quality deficiencies and actively participate in resolving issues.
  • Lead clinical site GCP auditing activities to ensure studies are conducted in accordance with sponsor protocols, GCP, and agency regulations.
  • Prepare company and clinical sites for customer audits and regulatory GCP inspections.

The ideal candidate should have a good scientific background, ideally with a Master's or Ph.D. in Biology, Biotechnology, Life Sciences, or a related field. 3-5 years of experience in clinical quality oversight is required, with a complete understanding of clinical research procedures and excellent English language skills.



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