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Associate Director Quality Compliance

VirtualVocations
Manchester, New Hampshire, United States
Full-time

A company is looking for an Associate Director, Clinical Operations - Quality & Compliance.Key ResponsibilitiesLead initiatives to foster a culture of quality within Clinical OperationsDevelop and maintain Inspection Readiness activities for key programsCollaborate with clinical study teams on risk management and mitigation activitiesRequired QualificationsBA or BS with 10+ years of experience in compliance in the pharmaceutical / biotechnology industryStrong knowledge of FDA, EMA, ICH guidelines, and GCP regulationsDirect experience at the Sponsor level with inspection operationsExperience with clinical systems, TMF, RBQM, and vendor quality oversight preferredAbility to analyze complex situations and develop regulatory-compliant solutions

15 days ago
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