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Parexel is seeking a highly experienced Senior Quality Assurance Auditor to join our team. As a key member of our quality assurance team, you will play a crucial role in ensuring the highest standards of quality and compliance in our clinical research operations.
Key Responsibilities- Conduct Audits and Assessments: Plan, conduct, and manage internal and external audits to evaluate the quality system against regulatory requirements, procedures, and guidelines.
- Lead Audit Programs: Independently lead audit programs, including project-related audits, system and process audits, supplier qualification and re-qualification audits, and Trial Master File audits.
- Develop and Implement Quality Initiatives: Collaborate with QA Management to develop and implement quality initiatives, process improvements, and regulatory compliance strategies.
- Provide Consultation and Expertise: Provide consultation and interpretation on regulatory compliance to internal and external clients, Parexel management, and staff.
- Support Quality Events and Investigations: Support Serious Breaches (SB) investigations and oversee project teams to reach final conclusions regarding reportability of critical Quality Events.
- Experience: Significant experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant areas.
- Knowledge and Skills: Excellent knowledge of Good Practices (GxPs) and international, national, and local regulations and laws related to clinical trials and other clinical research.
- Education: Bachelor's Degree or other relevant experience required. Life-science, health, or industry-related discipline preferred.
