PPhilogen is looking for a “strongClinical Quality Assurance Specialist (GCP) /strong”. 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. /ppbr/ppstrongIn particular the successful candidate will be responsible to: /strong /pulliMaintain GCP/ICH compliant systems and processes which control the quality of work and clinical trials conducted in Europe and US. /liliWrite and/or review clinical SOPs and support continuous process improvements. /liliManage training of staff on company procedures, GCP regulations, and documentation systems. /liliQualify CRO and other vendors related to the clinical activity. /liliPerform documentation control in the TMF and quality reviews of clinical trial essential documents and associated documentation (including Protocols, Investigator’s Brochure, CRFs, etc.) as appropriate. /liliPerform 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. /liliReport significant clinical quality deficiencies and/or risks to upper management and actively participate in solving the issues. /liliPerform clinical site GCP auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations. /liliLead role to prepare company and clinical sites for customer audits and regulatory GCP inspections. Participate as Subject Matter Expert during regulatory GCP inspections. /li /ulpbr/ppbr/ppstrongThe ideal candidate should have: /strong /pulliA good scientific background (ideally MSc. in Biology, Biotechnology, Life Sciences, etc.). /liliIdeally 3-5 years of experience in Clinical Quality oversight (clinical QA experience in the pharmaceutical industry required). /liliA complete understanding and application of principles, concepts and practices of clinical research procedures is required. /liliA high level of English language, both written and spoken. /liliA high level of attention to detail. /liliThe ability to work independently, to prioritize her/his own work as well as to prioritize task and coordinate other team members. /liliExcellent interpersonal skills, ability to work in teams, flexibility in changing tasks and priorities and motivation for new challenges. /li /ulpbr/ppstrongLocation: /strong /ppSiena (SI) - Italy /ppbr/ppemWe invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief. /em /p