Quality Manager- Dietary Supplements & Functional Foods
PURPOSE STATEMENT:
The Quality Manager (Dietary Supplements & Functional Foods) is responsible for ensuring that all dietary supplement products manufactured by Blueroot Health’s contract manufacturing partners are produced in compliance with 21 CFR Part 111, established Quality Agreements, and Blueroot Health quality standards. This position serves as the primary quality interface between Blueroot Health and its external manufacturing network, owning supplier and contract manufacturer qualification, quality agreements, on-site audits, batch record review, complaint and adverse event coordination, and CAPA management for externally manufactured product. The Quality Manager works cross-functionally with the in-house Quality team, R&D, Operations, Regulatory, and external partners to maintain a unified quality system across Blueroot Health’s combined in-house and external manufacturing footprint.
WHAT YOU’LL DO (MAJOR RESPONSIBILITIES):
- Partner Qualification: Lead audits and risk assessments to qualify and tier new contract manufacturers (CMOs) and raw material suppliers.
- Quality Agreements: Author, negotiate, and maintain legally binding Quality Agreements with all external manufacturing partners.
- On-Site Audits: Conduct annual and "for-cause" quality audits of external facilities; track corrective actions and maintain supplier scorecards.
- Batch Disposition: Review batch production records (BPRs), Certificates of Analysis (CoAs), and identity testing data to approve or reject finished batches prior to release.
- Deviations & CAPA: Investigate out-of-specification (OOS) results, manage external change control requests, and drive robust root cause analysis with partners.
- Complaints & Adverse Events: Triage product complaints, lead CMO investigations, and ensure 15-day MedWatch reporting compliance for serious adverse events.
- Regulatory Representation: Serve as the primary quality interface for external partners during FDA inspections, NSF/USP certifications, and third-party audits.