Quality Operations Manager
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Job Summary
The fully remote Quality Operations Manager will oversee the implementation and maintenance of the Quality Management System (QMS), manage quality events and CAPA programs, and ensure compliance with regulatory standards in a central laboratory supporting clinical trials.
Key responsibilities
- Champion quality initiatives and ensure alignment with global regulatory standards
- Manage Quality Events from issue identification through investigation and corrective action implementation
- Prepare for and facilitate audits and inspections, coordinating timely resolution of findings
Required qualifications
- Bachelor's degree in life sciences, medical technology, or a related field
- Minimum 4 years of experience in a central lab or clinical trial lab environment, with at least 2 years in a quality management role
- Strong understanding of CFRs, CLIA, CAP, GCP, and ICH guidelines
- Experience with quality management systems and audit processes
- Professional quality certifications are optional
Complete Job Description
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