Job 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.

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