Senior Principal Quality Auditor (Remote)

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 continuePrecision 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.)SkillsExcellent interpersonal and problem-solving skills, effective verbaland written communication, computer skillsCompetenciesStrong knowledge of GCP/ICH guidelines and FDA regulations and industrystandardsIntermediate proficiency in Microsoft Word, Excel, and PowerPoint, andsome knowledge of Access or similar databaseMust possess a customer service demeanor; demonstrate collaboration andflexibility, teamwork, and a keen attention to detailAbility to work independently and in a team environmentAbility to work with cross functional groups and management underchallenging situationsAbility to prioritize work and handle multiple and/or competingassignmentsExcellent verbal and written communications skillsMust be fluent in the English languageAt Precision for Medicine, we believe that the era of one-size-fits-allmedication is giving way to a next generation of treatments, medicines thatwill be more effective because they are prescribed according to the uniquebiology of an individual patient. Our mission is to help innovative biotechand pharmaceutical companies accelerate the development of theselife-changing treatments. Precision does this by developing assays thatutilize biomarkers to help identify the right patient for the right drug.We handle every aspect of clinical trials from initial strategy and designto selecting sites and executing quality clinical trials. This is where youcome in!Any data provided as a part of this application will be stored inaccordance with our Privacy Policy. For CA applicants, please also refer toour CA Privacy Notice .Precision Medicine Group is an Equal Opportunity Employer. Employmentdecisions are made without regard to race, color, age, religion, sex,sexual orientation, gender identity, national origin, disability, veteranstatus or other characteristics protected by law.2020 PrecisionMedicine Group, LLCIf you are an individual with a disability and require a reasonableaccommodation to complete any part of the application process or arelimited in the ability or unable to access or use this online applicationprocess and need an alternative method for applying, you may contactPrecision Medicine Group at ****** . Show more Show lessTagged as: remote, remote job, virtual, Virtual Job,virtual position, Work at Home, work from homeWhen applying state you found this job onPangian.com Remote Network.#J-18808-Ljbffr