The Manager leads inspection readiness and administration; internal, supplier, corporate, customer, and regulatory audits; Quality Management Review and Quality Review Board programs; Annual Product Quality Reviews; Field Alert and other regulatory notifications; data integrity oversight; and recall readiness. Conduct or oversee complex internal, external, and supplier audits to evaluate manufacturing, quality, production, and support areas for compliance with cGMPs, company procedures, and other applicable requirements and to identify quality gaps, data-integrity risks, and compliance deviations.