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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Audit Specialist (Sponsor Audits and Inspections)
Job ID R0000031164 Prague, Hlavní město Praha, CzechiaAudit Specialist (Sponsor Audits and Inspections)
Location: Lithuania, Poland, Spain, Czechia, 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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