Manager, Quality Compliance
On-site · Gainesville, Georgia, United States
Job Summary
Quality Assurance & Compliance Manager will oversee all quality operations at a high-volume manufacturing facility, ensuring compliance with FDA, GMP, ISO and other standards; lead QA team, investigations (NCPs, deviations, CAPA), change control, and annual product reviews; drive internal and external audits, audit readiness, and CAPA implementation; champion Lean/Six Sigma and continuous improvement; monitor KPIs and provide updates to leadership; travel up to 10–15% for audits, training, and corporate meetings; collaborate across functions on product integrity and quality initiatives; education includes Bachelor's in Chemistry/Engineering/Life Sciences (Master’s preferred); 7–9 years of progressive QA experience with leadership roles; auditor certification preferred.
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
- Auditor certification (ASQ CQA, ISO Lead Auditor) (Preferred)
- Licenses and Certifications: Auditor certification (ASQ CQA, ISO Lead Auditor) (Preferred)
- Experience leading QA teams, CAPA management, regulatory compliance
Additional Requirements
- Relocation not specified
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.