Senior Quality Assurance Auditor
1 month ago
At Parexel, we are seeking a highly skilled Senior Quality Assurance Auditor to join our team of experts in clinical research. As a Senior Quality Assurance Auditor, you will play a critical role in ensuring the quality and integrity of our clinical research operations.
Key Responsibilities:- Lead and perform GxP audits across all phases of clinical research
- Develop and execute strategic audit plans to ensure compliance with regulatory requirements
- Manage and coordinate internal regional and global process/system audits
- Report outcomes and trends of audit programs to QA Senior Management
- Review audit reports, responses, and other program deliverables to ensure high-quality standards
- Act as QA Lead on audits programs
- Support Serious Breaches (SB) investigations and oversee project teams to reach final conclusions
- Support auditor training and mentoring of new/less experienced auditors
- Maintain QA records/systems and process improvements
- Provide local, regional, and global consultancy and interpretation on regulatory compliance
- Support Sponsor Audits and Regulatory Inspections
- 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
- Ability to travel internationally for audits as required (up to 60% travel time)
- 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 rapidly learn, understand, and apply applicable Parexel and client procedures
- Client-focused approach to work
- Excellent interpersonal, verbal, and written communication skills
- Ability to mentor/train auditors and other personnel
- Flexible attitude to work assignments and new learning
- Ability to diplomatically address sensitive issues confidentially and professionally
- Competitive salary and benefits package
- Opportunities for professional growth and development
- Collaborative and inclusive work environment
- Flexible working hours and work-life balance
- Pet insurance and other employee benefits
Parexel is an equal opportunity employer and welcomes applications from qualified candidates without regard to legally protected status.
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