Director of Clinical Quality Assurance
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Job Summary
Providing hands-on execution for GCP quality assurance and regulatory inspection readiness, the full-time Director of Clinical Quality Assurance will implement quality strategies, conduct audits, and serve as a subject matter expert while maintaining a regular presence in the New Providence, NJ office.
Key responsibilities
- Perform GCP audits and contribute to the development of GCP audit schedules
- Manage regulatory inspection activities, including developing inspection plans and facilitating mock inspections
- Implement scalable quality processes and maintain the Clinical Quality Manual
Required qualifications
- BS/BA degree in a scientific or health-related discipline or relevant certification (e.g., RN, NP, PharmD)
- Minimum of 10 years of experience in the biopharmaceutical industry or at a Contract Research Organization in Clinical R&D
- Experience in clinical quality risk management, quality assurance, or GCP auditing roles
- Extensive knowledge of ICH GCP and relevant global regulations
- Experience in hematology/oncology trials is highly preferred
Complete Job Description
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