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Inicio Inmediato! Associate Director Quality Assurance...
BioPhaseLima Metropolitana, Lima, PEHace 22 días
Descripción del trabajoBachelor’s in life sciences or engineering with 7+ years of GCP experience, or Master’s with 4+ years. CQA or audit certifications a plus. Experience with TMF or electronic document systems preferred. In-depth knowledge of ICH GCP E6 (R2). Strong auditing, organizational, and communication skills. Ability to manage multiple priorities in a dynamic environment. Remote role with flexible hours. Travel up to 30% may be required. Mid-Senior level Full-time Other Biotechnology Research and Pharmaceutical Manufacturing
Overview
Senior GCP Auditor – Remote at BioPhase Solutions
The Senior GCP Auditor ensures compliance with SOPs, ICH GCP E6 (R2), FDA regulations, and study protocols. This role supports inspection readiness and collaborates cross-functionally with Clinical Operations, Regulatory, PV, Medical Writing, and Data Management.
Compensation
$130,000.00 / yr - $145,000.00 / yr
Responsibilities
- Maintain and update the Clinical Trial Quality Management System.
- Plan and conduct internal, vendor, and clinical site audits.
- Prepare audit documentation and follow up on findings and CAPAs.
- Review protocols, ICFs, and study-related documents for compliance.
- Support GCP training and quality issue resolution across departments.
- Track deviations, CAPAs, and complaints.
- Lead inspection readiness initiatives and assist during regulatory inspections.
- Represent QA in cross-functional meetings.
Qualifications
Skills
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Inicio Inmediato • Lima Metropolitana, Lima, PE