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Clinical Quality Assurance Manager

2 mesi fa

Siena, Toscana, Italia Philogen A tempo pieno
Job Title: Clinical Quality Assurance Manager (GCP)

Job Summary:

Philogen S.p.A. is seeking a highly skilled Clinical Quality Assurance Manager (GCP) to strengthen its office of clinical quality assurance. The successful candidate will be responsible for assessing compliance with SOPs, GxP, European regulations, local regulations, and clinical study protocols.

Key Responsibilities:

  • Maintain GCP/ICH compliant systems and processes that control the quality of work and clinical trials conducted in Europe and the US.
  • Develop and/or 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 and associated documentation.
  • Perform routine internal System and TMF audits and checks throughout the lifecycle of a trial/program to ensure compliance with internal procedures and regulatory guidelines.
  • Report significant clinical quality deficiencies and/or risks to upper management and actively participate in solving the issues.
  • Perform clinical site GCP auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations.
  • Lead role to prepare company and clinical sites for customer audits and regulatory GCP inspections.

Requirements:

  • A good scientific background (ideally 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).
  • A complete understanding and application of principles, concepts, and practices of clinical research procedures.
  • A high level of English language, both written and spoken.
  • A high level of attention to detail.
  • The ability to work independently, to prioritize own work as well as to prioritize tasks and coordinate other team members.
  • Excellent interpersonal skills, ability to work in teams, flexibility in changing tasks and priorities, and motivation for new challenges.