Associate Director Quality Assurance (Pueblo Libre) (Lima)...

OverviewSenior GCP Auditor – Remote at BioPhase SolutionsThe 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,

• / yr - $145,
• / yrResponsibilities- 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- Bachelor'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.Skills- In-depth knowledge of ICH GCP E6 (R2). - Strong auditing, organizational, and communication skills. - Ability to manage multiple priorities in a dynamic environment.Additional info- Remote role with versátil hours. - Travel up to 30% may be required.Seniority level- Mid-Senior levelEmployment type- Full-timeJob function- OtherIndustries- Biotechnology - Research and Pharmaceutical Manufacturing#J-
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