Overview When our values align, there's no limit to what we can achieve.Audit Specialist (Sponsor Audits and Inspections)Location: Lithuania, Poland, Spain, Czechia, UK, Italy, Hungary, or RomaniaPlease note: Candidates must already be based in one of the listed countries with existing right to work. We are unable to provide visa sponsorship or relocation support for this role.About the Role We're looking for an experienced Audit Specialist to lead Sponsor Audits and Regulatory Inspections across our European operations. You'll provide expert guidance to project teams, drive audit preparation activities, and ensure all inspections are managed with the highest quality standards.What You'll Do Lead GxP Audits: Independently plan, conduct, and report on audits across all clinical research phases, including project audits, system audits, supplier qualifications, TMF audits, and pharmacovigilance auditsDeliver Quality Results: Complete high-quality audit reports within timelines and budgets, including complex for-cause and co-audits with clientsDrive Compliance: Support Serious Breach investigations, provide regulatory guidance on GxP requirements, and facilitate client audits and regulatory inspectionsEnsure Follow-up: Review CAPA responses, escalate delays, and consult with Operations and Quality teams on implementationContribute to Excellence: Help develop and improve Parexel procedures, systems, and audit strategiesWhat You'll Need Experience:Practical experience in GxP environments (GCP and/or GVP standards preferred)Background in Quality Management/Quality Assurance with hands-on involvement in external audits and regulatory inspectionsSkills:Fluent English (spoken and written) and good level of the local language of the country you are applying fromProficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint, Teams/SharePoint)Strong decision-making ability with quick analytical thinkingExcellent communication skills at all organizational levelsHigh adaptability to respond to fast-moving, externally driven changesDemonstrated leadership and ability to influence cross-functional teamsWillingness to travel occasionallyEducation Bachelor's Degree (Life Science, Health, or industry-related discipline preferred)
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