Precision for Medicine is hiring a Senior/Principal Quality Auditor to join our team, candidates can be based in either UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia.Position Summary:The Senior/Principal Quality Auditor supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures. Essential functions of the job include but are not limited to: Support the Quality Management System including SOPs, training and CAPAProcess and maintain documentation for controlled documents, as requiredDevelop 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 change control processProvide QA consultation and support to assigned project teams internally and externallySupport and manage reported quality issues and any associated corrective and preventive actionsMonitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvementMaintains Q&C trackers, databases, metrics, and filesFollow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH, ISO and company policies and proceduresAdditional tasks as required Qualifications:Minimum Required: Requires two to five years of applicable experience or equivalent combination of education and experienceClinical research experience in non-QA role considered (e.g., clinical research associate experience)Working knowledge of GCP/ICH guidelines and FDA regulations and standardsHands-on experience leading clinical site audits Other Required: Bachelor's degree in a science, healthcare, or related field of studyAvailability to travel up to 50% domestically and/or internationally Preferred: CRO, 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.) Skills: Excellent interpersonal and problem-solving skills, effective verbal and written communication, computer skills Competencies: Strong knowledge of GCP/ICH guidelines and FDA regulations and industry standardsIntermediate proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar databaseMust possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and a keen attention to detailAbility to work independently and in a team environmentAbility to work with cross functional groups and management under challenging situationsAbility to prioritize work and handle multiple and/or competing assignmentsExcellent verbal and written communications skillsMust be fluent in the English language At Precision for Medicine, we believe that the era of one-size-fits-all medication is giving way to a next generation of treatments, medicines that will be more effective because they are prescribed according to the unique biology of an individual patient. Our mission is to help innovative biotech and pharmaceutical companies accelerate the development of these life-changing treatments. Precision does this by developing assays that utilize biomarkers to help identify the right patient for the right drug. We handle every aspect of clinical trials from initial strategy and design to selecting sites and executing quality clinical trials. This is where you come in!#LI-NC1 #LI-Remote
