Philogen S.p.A. is looking for a “Clinical Quality Assurance Senior Specialist (GCP)
” who will report to the GCP Quality Assurance Manager. The position will be responsible to assess 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.
In particular the successful candidate will be responsible for:
Maintain GCP/ICH compliant systems and processes which control the quality of work and clinical trials conducted in Europe and US.
Review and/or Approval of clinical SOPs and support continuous process improvements
Perform Quality reviews of clinical trial protocols and associated documentation (including informed Consent Documents, CRFs, etc.) as appropriate.
Perform routine internal System and TMF audits and checks throughout the lifecycle of a trial/program to ensure compliance with internal procedures as well as regulatory guidelines.
Report significant clinical quality deficiencies and/or risks to QA management and actively participate in solving the issues.
Perform GCP auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations.
Lead preparation of the company and clinical sites for customer audits and regulatory GCP inspections. Participate as Subject Matter Expert during regulatory GCP inspections
Manage training of staff on company procedures, GCP regulations, and documentation systems.
The ideal candidate should have:
A good scientific background (ideally Master/ PhD in Biology, Biotechnology, etc.)
Ideally 3-5 years of experience in Clinical Quality oversight (QA experience in the Pharmaceutical industry required).
A complete understanding and application of principles, concepts and practices of clinical research procedures is required.
A high level of English language, both written and spoken;
A high level of attention to detail;
The ability to work independently, to prioritize her/his own work as well as to prioritize task and coordinate other team members;
Excellent interpersonal skills, ability to work in teams, flexibility in changing tasks and priorities and motivation for new challenges.
Sovicille (Siena) - Italy
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address firstname.lastname@example.org, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).