Quality Auditor Lead

2 weeks ago


Uxbridge, United Kingdom Parexel Full time
About the Role:

We are looking for a highly skilled Tech Compliance Specialist to join our team at Parexel. As a Tech Compliance Specialist, you will be responsible for ensuring compliance with industry standards and regulations by leading, performing, and reporting audits. Your experience and knowledge will enable you to provide high-level guidance and leadership in conducting audits that impact business operations, processes, and systems.

You will lead, perform, and report audits, manage technology audits, and lead and coordinate internal audit programs globally and regionally. Additionally, you will support serious breaches, auditor training and mentoring, maintain QA records and systems, support sponsor audits and regulatory inspections, and promote compliance within Parexel. The successful candidate will have experience with Microsoft-based applications, the ability to learn internal and supplier computer systems, and the willingness to work effectively with multiple supervisors in a matrix environment.

The ideal candidate will possess strong knowledge of GxP, industry standards, and applicable international technology compliance regulations. They should be detail-oriented, able to maintain a 'big picture' overview during a sponsor audit or inspection, and have excellent time management skills. Familiarity with technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems, is also essential. Furthermore, the candidate should be educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred) or equivalent qualification or clinical research experience.



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