Associate Director Quality Assurance (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,
• / yrResponsibilitiesMaintain 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.QualificationsBachelor'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.SkillsIn-depth knowledge of ICH GCP E6 (R2). Strong auditing, organizational, and communication skills.Ability to manage multiple priorities in a dynamic environment.Additional infoRemote role with adaptable hours.Travel up to 30% may be required.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionOtherIndustriesBiotechnologyResearch and Pharmaceutical Manufacturing #J-
• Ljbffr

#J-18808-Ljbffr