Audit Specialist – Sponsor Audits, Inspections
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Job Description
Audit Specialist responsible for leading Sponsor Audits and Regulatory Inspections in Europe at Parexel. Providing expert guidance and ensuring compliance with high-quality standards.
Responsibilities:
- 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
Requirements:
- 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
- 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
Benefits:
- Professional development opportunities
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