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Skills
Accreditation Standardsunmatched
Biologyunmatched
Business Growthunmatched
Business Operationsunmatched
Business Skillsunmatched
Business Strategyunmatched
Business Supportunmatched
Chemistryunmatched
Code of Federal Regulationsunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Dietary Managementunmatched
Documentationunmatched
Drug Manufacturingunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
Food Scienceunmatched
Leadershipunmatched
Maintain Complianceunmatched
Mentoringunmatched
NSF Audio Formatsunmatched
NSF International (National Sanitation Foundation)unmatched
Operationsunmatched
Quality Assuranceunmatched
Quality Controlunmatched
Quality Managementunmatched
Quality Metricsunmatched
Regulatory Complianceunmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Supply Chainunmatched
Team Lead/Managerunmatched
United States Department of Agriculture (USDA)unmatched
Description
Position Summary The Quality Assurance (QA) Manager leads the quality department, drives strategic quality initiatives, and successfully balances strict regulatory compliance with the commercial goals and growth timelines of the business.
Key Responsibilities
Strategic Leadership: Drive the long-term vision for the quality department to support business growth and operational scaling.
Team Management: Lead, mentor, and develop the daily operations of the QA/QC team.
Commercial Alignment: Balance strict regulatory compliance with commercial needs, minimizing production bottlenecks and optimizing speed-to-market.
Regulatory Compliance: Enforce cGMP compliance in strict accordance with FDA 21 CFR Part 111 regulations.
Certification Management: Oversee and maintain NSF International dietary supplement certification requirements.
Organic Compliance: Manage USDA Organic certification standards, including identity preservation and supply chain documentation.
Audits and Inspections: Lead third-party (NSF, Organic certifying agencies), customer, and FDA regulatory plant inspections.
Risk Management: Direct root-cause analysis for out-of-specification (OOS) results, deviations, and Corrective and Preventive Actions (CAPA).
Qualifications and Requirements
Education: Bachelor’s degree in Chemistry, Biology, Food Science, or a related scientific field.
Experience: 5+ years of QA/QC leadership in dietary supplement or pharmaceutical manufacturing.
Business Acumen: Proven track record of aligning quality metrics with business objectives and commercial timelines.
Certifications: Active certifications or direct experience handling NSF cGMP registry requirements.
Skills: Expert knowledge of cGMP audits, organic handling plans, and cross-functional corporate strategy.