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Quality Compliance Audit Manager

Advatix

Lead quality compliance, audits, and corrective action programs in a full-time management role based in Detroit, Maple Grove, South Bend, or Chicago.The Compliance and Quality Assurance Manager leads quality, regulatory, and audit programs across assigned operations. This manager oversees QMS development, ISO 9001, GMP, FDA, customer, and internal requirements. The role guides site leadership, manages compliance teams, and drives risk mitigation and continuous improvement.Key Responsibilities:
Lead QMS development, implementation, maintenance, and improvementManage internal, customer, ISO, FDA, security, and regulatory auditsOwn CAPA, root cause analysis, and corrective action effectivenessLead compliance professionals and develop team performancePresent compliance trends and risk strategies to senior leadershipRequirements:
Bachelor's degree in a related field preferredFive years of quality, compliance, regulatory, or operational excellence experienceThree years of leadership experience managing teamsExperience supporting ISO 9001 environmentsKnowledge of GMP, FDA, CAPA, and quality management systemsApply quality systems, audit management, CAPA, and regulatory expertise across assigned operations while supporting continuous improvement.
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Vacancy posted more than 2 months ago

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