Senior Quality Manager

The Role

As Senior Quality Manager at ULTRA, you’ll own quality systems across the entire supply chain—from raw material suppliers through co-manufacturers and distributors to the end consumer. You’ll build and run the external audit program, stand up the consumer complaint management system, and establish the supplier qualification standards that ensure every pouch meets specification and regulatory requirements under 21 CFR Part 111.

This is a build role. You won’t be maintaining someone else’s systems—you’ll be standing them up from scratch. If you thrive on creating structure where there is none and want to define quality for the fastest-growing pouch brand in the market, this is your opportunity.

What You’ll Own

• Co-Manufacturer Auditing
• Develop and execute a risk-based audit schedule covering all co-manufacturers.
• Conduct on-site and remote audits assessing GMP compliance, sanitation, documentation practices, and batch record integrity.
• Issue audit reports, track corrective and preventive actions (CAPA), and verify closure within defined timelines.
• Maintain audit readiness for internal facilities, including The ULTRA Compound (R&D lab).

• Consumer Complaint Management
• Build and own an end-to-end system to capture, categorize, track, investigate, and respond to consumer complaints.
• Establish triage criteria, investigation workflows, and escalation paths for adverse events and product quality issues.
• Lead root-cause investigations and drive CAPA through to resolution.
• Generate trend analyses and reporting to surface systemic issues and inform formulation, process, and labeling decisions.
• Manage regulatory reporting obligations for serious adverse events.

• Supplier Qualification
• Define and administer the supplier qualification and approval program for raw materials, excipients, and packaging.
• Review Certificates of Analysis, specifications, and identity testing requirements, including botanical extract identity under 21 CFR Part 111.
• Conduct supplier risk assessments, approve or disapprove suppliers, and maintain the Approved Supplier List.
• Manage supplier change controls, requalification, and ongoing performance monitoring.

• Quality Systems & Compliance
• Maintain and continuously improve the quality management system (SOPs, specifications, batch records, deviation and change control).
• Ensure compliance with 21 CFR Part 111 and applicable dietary supplement regulations.
• Partner with Product Development on specification setting, stability, and release testing.