Audit Specialist (Sponsor Audits and Inspections)
Primary Location: Serbia, Belgrade Additional Locations: Czech Republic, Prague; Hungary, Budapest; Italy, Milan; Lithuania, Vilnius; Poland, Warsaw; Romania, Bucharest; Spain, Madrid; United Kingdom, Harrow Job ID R0000031164 Category Quality ManagementAbout this Role
Audit Specialist (Sponsor Audits and Inspections)
Location: Lithuania, Poland, Spain, Czechia, Serbia, UK, Italy, Hungary, or Romania
Please 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 Specialistto 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 audits
- Deliver Quality Results:Complete high-quality audit reports within timelines and budgets, including complex for-cause and co-audits with clients
- Drive Compliance:Support Serious Breach investigations, provide regulatory guidance on GxP requirements, and facilitate client audits and regulatory inspections
- Ensure Follow-up:Review CAPA responses, escalate delays, and consult with Operations and Quality teams on implementation
- Contribute to Excellence:Help develop and improve Parexel procedures, systems, and audit strategies
What 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 inspections
Skills:
- Fluent English(spoken and written) and good level of the local language of the country you are applying from
- Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint, Teams/SharePoint)
- Strong decision-making ability with quick analytical thinking
- Excellent communication skills at all organizational levels
- High adaptability to respond to fast-moving, externally driven changes
- Demonstrated leadership and ability to influence cross-functional teams
- Willingness to travel occasionally
Education:
- Bachelor's Degree (Life Science, Health, or industry-related discipline preferred)
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