Senior Manager, Quality & Regulatory Affairs

📋 Description

• Lead day-to-day quality and performance management for contract manufacturers and key suppliers
• Develop and maintain quality agreements with contract manufacturing organizations and strategic
• Lead contract manufacturer qualification and audit programs, including initial qualification
• Serve as the primary quality contact for manufacturing deviations, out-of-specification results
• Manage the third-party laboratory program, including laboratory qualification, testing method
• Develop and maintain specifications for raw materials, components, and finished products while

🎯 Requirements

• 8+ years of experience in quality assurance and/or regulatory affairs within dietary supplements
• Strong working knowledge of FDA requirements, including 21 CFR Part 111 and DSHEA, as well as
• Demonstrated experience managing contract manufacturer quality within a brand-owner environment
• Hands-on experience conducting contract manufacturing facility audits and driving corrective and
• Familiarity with FDA and Health Canada regulatory requirements and processes; direct experience
• Experience supporting adverse event reporting and related regulatory obligations.

🎁 Benefits

• Full-time, permanent position.
• Fully remote work, with applicants considered across the United States and Ontario, Canada.
• Health benefits provided from Day 1.
• Unlimited time off.
• Participation in the employee options program.
• Opportunity to lead quality and regulatory strategy across US and Canadian markets.