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Senior Quality Assurance Auditor
2 months ago
Parexel is seeking a highly skilled Senior Quality Assurance Auditor to join our team. As a Senior Quality Assurance Auditor, you will be responsible for leading, planning, scheduling, performing, and reporting a range of GxP audits across all phases of Clinical Research.
Key Responsibilities:- Lead and manage GxP audits, ensuring compliance with regulatory requirements and Parexel policies.
- Develop and execute strategic audit plans, working closely with internal customers to identify areas for improvement.
- Collaborate with cross-functional teams to ensure seamless execution of audits and implementation of corrective actions.
- Provide expert guidance on regulatory compliance, interpreting and applying relevant GxP requirements.
- Support auditor training and mentoring, sharing knowledge and experience to enhance the skills of junior auditors.
- Contribute to process improvements, optimizing new and existing processes to maintain and improve quality standards.
- Liaise with external industry and regulatory inspectorate contacts to stay up-to-date on best practices and regulatory developments.
- Minimum of 2 years' experience in quality assurance, auditing, including sound experience of applicable GxP auditing.
- At least 5 years' experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science.
- Excellent knowledge, understanding, and experience of Good Practices (GxPs) and international, national, and local regulations and laws related to clinical trials and other clinical research.
- Ability to travel internationally for audits as required, with a potential travel time of up to 60%.
- A collaborative and inclusive work environment that values your expertise.
- Professional growth and development opportunities to unlock your full potential.
- A comprehensive benefits package, including health, vision, and dental insurance, tuition reimbursement, and a 401(k) with company match.
Parexel is an equal opportunity employer, committed to diversity and inclusion. Qualified applicants will receive consideration for employment without regard to legally protected status.
