.Senior Principal Quality Auditor (Remote) Senior Principal Quality Auditor | Precision For Medicine |SpainPrecision for Medicine is hiring a Senior/Principal QualityAuditor to join our team, candidates can be based in either UK, Spain,Hungary, Poland, Romania, Serbia or Slovakia.... Login to continue Precision for Medicine is hiring a Senior/Principal QualityAuditor to join our team, candidates can be based in either UK, Spain,Hungary, Poland, Romania, Serbia or Slovakia.Position SummaryThe Senior/Principal Quality Auditor supports the audit programand clinical projects to ensure compliance with regulations and Precisionprocedures.Essential functions of the job include but are not limited to:Support the Quality Management System including SOPs, training andCAPAProcess and maintain documentation for controlled documents, asrequiredDevelop and administer training for employees and/or consultantsHost client/sponsor audits and support regulatory inspectionsCoordinate and conduct assessments of potential and contracted vendors,including vendor audits as warrantedCoordinate and conduct internal audits of quality systemsCoordinate and conduct investigator site auditsCoordinate and conduct trial master file auditsParticipate on computer systems validation projects and systems changecontrol processProvide QA consultation and support to assigned project teamsinternally and externallySupport and manage reported quality issues and any associatedcorrective and preventive actionsMonitor quality systems to provide feedback on compliance risks to QAmanagement and identify opportunities for improvementMaintains Q&C trackers, databases, metrics, and filesFollow applicable regulations and standards, including but not limitedto local regulations (US FDA and EU), ICH, ISO and company policies andproceduresAdditional tasks as requiredQualificationsMinimum Required:Requires two to five years of applicable experience or equivalentcombination of education and experienceClinical research experience in non-QA role considered (e.G., clinicalresearch associate experience)Working knowledge of GCP/ICH guidelines and FDA regulations andstandardsHands-on experience leading clinical site auditsOther RequiredBachelor's degree in a science, healthcare, or related field ofstudyAvailability to travel up to 50% domestically and/or internationallyPreferredCRO, Pharmaceutical and/or Medical device experienceQA certification preferred (e.G., CQA, SQA, etc.)Experience with electronic clinical trial systems (e.G., EDC, CTMS,IxRS, ePRO, etc
