Quality Assurance Manager

Quality Assurance ManagerSan Diego, California, United StatesQuality Assurance ManagerThe primary responsibility of this position is to oversee GxP activities and maintain the effective quality system within the company. This position will report directly to CEO and work closely with our CMC and Clinical Operations teams to ensure the compliance of relevant regulatory. The duties include but not limited to maintain appropriate document system, review/approve critical documents and perform the audit internally or externally.Main Job Tasks and ResponsibilitiesResponsible for QAU administration.The maintenance of the document management system.Identify training needs and organize training interventions to meet quality standardsPerform the internal/external audit and finalize the audit reportEvaluate audit findings and ensure appropriate corrective as well as preventive actions in place if applicableCooperate with internal team/external parties to investigate customer complaints and non-conformance issuesAnalyze data to identify areas for improvement in the quality systemAdditional duties as required and assignedMust HaveB.S. or M.S. in sciencesPrior experience as a QA AuditorAuditing experience of GMP quality standardsAbility to analyze and sort problems in a logical way with root cause analyses of non-compliance and CAPANice-to-HaveWorking experience with CMO/CRO/Outsourcing Testing Lab (OTL)Drug substance/product or pharmaceutical industry-specific experienceCertifications an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six SigmaAuditing experience of GCP quality standardsExperience with implementation of corrective/preventive action programsKnowledge of relevant regulatory requirements (FDA GxP regulations and ICH guidelines)Key Competenciesattention to detailcommunication skills - verbal and writtendata collection, management and analysisproblem analysis and problem solvingplanning and organizingjudgmentdecision-makingteamwork