Manager, Quality Compliance
On-site · Gainesville, Georgia, United States
Job Summary
QA Compliance Manager leading quality operations at a high-volume manufacturing facility. Will oversee investigations (NCPs, deviations, CAPA), change control, plant procedures, and annual product reviews; manage internal audits and serve as site contact for external audits; ensure compliance with FDA, GMP, ISO, and other standards; monitor KPIs and drive CAPA effectiveness. Responsible for calibration, training (cGMP, role-specific modules), complaint handling with trend analysis; champion Lean, Six Sigma, and other quality methodologies; collaborate cross-functionally to resolve product integrity issues and participate in strategic projects. Travel up to 10–15% for audits, training, and corporate meetings; lead and mentor QA teams to align quality objectives with regulatory requirements and business goals; provide leadership in a regulated manufacturing environment.
Required Qualifications
- Bachelor's Degree in Chemistry, Engineering, Life Sciences, or related field; Master’s preferred
- 7-9 years years of progressive QA experience in regulated manufacturing (OTC, pharma, cosmetics, personal care) with 3+ years in leadership
- 7-9 years FDA regulations, GMP, ISO standards, electronic QMS platforms
- 7-9 years proven success leading audits, managing CAPA, and driving compliance initiatives
- 7-9 years communication, analytical, leadership, and problem-solving abilities
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