{"schemaVersion":"jobsearcher.job.v1","id":"f14ffa6afdb3e285e4493faa","url":"https://jobsearcher.com/jobs/f14ffa6afdb3e285e4493faa","canonicalUrl":"https://jobsearcher.com/jobs/f14ffa6afdb3e285e4493faa","title":"GxP Auditor","description":"GxP Auditor is an integral member of the Quality and Compliance team. The GxP Auditor is responsible for planning and conducting scheduled quality audits on behalf of RxCloud. This position will also act as a Subject Matter Expert (SME) for GxP auditing and quality projects and will be responsible for supporting the on‑going development and management of the Quality Management Auditing system. This position is responsible for independently managing quality/GxP auditing deliverables scheduled.\n\nResponsibilities\n\nFunction as a Quality/GxP auditor of both external CDMOs and clinical sites, and internal laboratory operations.\n\nDevelop and implement the global audit strategy, aligning with organizational goals and regulatory requirements.\n\nPerform audits across various departments and functional areas.\n\nConduct risk assessments to identify potential areas of concern and develop appropriate audit plans and procedures.\n\nReview and assess the effectiveness of internal controls, making recommendations for improvement to mitigate risks and strengthen processes.\n\nCollaborate with cross-functional teams, including finance, operations, compliance, and legal, to ensure audit findings are addressed and resolved.\n\nConduct investigations into allegations of fraud, unethical practices, or non‑compliance, and recommend appropriate actions to address such issues.\n\nPrepare comprehensive audit reports, including findings, recommendations, and action plans for management and key stakeholders.\n\nResponsible for leading, conducting, and documenting investigations relating to audit findings noted internally.\n\nUtilize root cause analysis tools, critical thinking, and interviewing techniques to determine the root and contributing causal factors of noted findings.\n\nEnsure audits are performed within budget and according to plan.\n\nFacilitate post‑audit debriefs with internal stakeholders within defined timeframes ensuring clear communication of audit findings.\n\nProduce draft and final versions of audit plans, reports and summaries within defined timeframes and in accordance with internal policies and procedures.\n\nPromote continual improvement regarding stakeholder satisfaction with emphasis on Quality/GxP auditing services.\n\nStay current with advances and technological changes in Quality/GxP services within the biotech industry and promote those that will increase effectiveness and knowledge.\n\nRequired Qualifications\n\nMinimum bachelor's degree in any scientific discipline.\n\nA minimum of 20 years of relevant experience including a minimum of 15 years of GxP auditing in a regulated environment focused on quality.\n\nExcellent knowledge of GxP regulatory requirements.\n\nExperience using electronic Quality Management Systems.\n\nAbility to manage multiple projects in a fast‑paced environment.\n\nAbility to collaborate effectively in a dynamic, cross‑functional matrix environment.\n\nAbility to understand when issues require escalation to Senior Quality Management.\n\nMust be detail oriented; must be precise and organized in handling of documents. Solid organizational skills required; must be able to prioritize multiple tasks.\n\n#J-18808-Ljbffr","company":"Rxcloud","rawCompany":"rxcloud","city":"Oregon","state":"WI","isRemote":false,"isActive":true,"createdAt":"2026-04-09T09:08:26.925Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"11-9199.02","title":"Compliance Managers","slug":"compliance-managers"},{"code":"11-9199.01","title":"Regulatory Affairs Managers","slug":"regulatory-affairs-managers"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541618","title":"Other Management Consulting Services","slug":"other-management-consulting-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"GxP Auditor","description":"GxP Auditor is an integral member of the Quality and Compliance team. The GxP Auditor is responsible for planning and conducting scheduled quality audits on behalf of RxCloud. This position will also act as a Subject Matter Expert (SME) for GxP auditing and quality projects and will be responsible for supporting the on‑going development and management of the Quality Management Auditing system. This position is responsible for independently managing quality/GxP auditing deliverables scheduled.\n\nResponsibilities\n\nFunction as a Quality/GxP auditor of both external CDMOs and clinical sites, and internal laboratory operations.\n\nDevelop and implement the global audit strategy, aligning with organizational goals and regulatory requirements.\n\nPerform audits across various departments and functional areas.\n\nConduct risk assessments to identify potential areas of concern and develop appropriate audit plans and procedures.\n\nReview and assess the effectiveness of internal controls, making recommendations for improvement to mitigate risks and strengthen processes.\n\nCollaborate with cross-functional teams, including finance, operations, compliance, and legal, to ensure audit findings are addressed and resolved.\n\nConduct investigations into allegations of fraud, unethical practices, or non‑compliance, and recommend appropriate actions to address such issues.\n\nPrepare comprehensive audit reports, including findings, recommendations, and action plans for management and key stakeholders.\n\nResponsible for leading, conducting, and documenting investigations relating to audit findings noted internally.\n\nUtilize root cause analysis tools, critical thinking, and interviewing techniques to determine the root and contributing causal factors of noted findings.\n\nEnsure audits are performed within budget and according to plan.\n\nFacilitate post‑audit debriefs with internal stakeholders within defined timeframes ensuring clear communication of audit findings.\n\nProduce draft and final versions of audit plans, reports and summaries within defined timeframes and in accordance with internal policies and procedures.\n\nPromote continual improvement regarding stakeholder satisfaction with emphasis on Quality/GxP auditing services.\n\nStay current with advances and technological changes in Quality/GxP services within the biotech industry and promote those that will increase effectiveness and knowledge.\n\nRequired Qualifications\n\nMinimum bachelor's degree in any scientific discipline.\n\nA minimum of 20 years of relevant experience including a minimum of 15 years of GxP auditing in a regulated environment focused on quality.\n\nExcellent knowledge of GxP regulatory requirements.\n\nExperience using electronic Quality Management Systems.\n\nAbility to manage multiple projects in a fast‑paced environment.\n\nAbility to collaborate effectively in a dynamic, cross‑functional matrix environment.\n\nAbility to understand when issues require escalation to Senior Quality Management.\n\nMust be detail oriented; must be precise and organized in handling of documents. Solid organizational skills required; must be able to prioritize multiple tasks.\n\n#J-18808-Ljbffr","datePosted":"2026-04-09T09:08:26.925Z","dateModified":"2026-04-09T09:08:26.925Z","hiringOrganization":{"@type":"Organization","name":"Rxcloud","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Oregon","addressRegion":"WI","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"f14ffa6afdb3e285e4493faa"},"url":"https://jobsearcher.com/jobs/f14ffa6afdb3e285e4493faa"}}