Bachelor's degree in a science discipline; Master's preferred.
Minimum 7 years of progressive Quality experience in dietary supplements, pharma, or regulated food manufacturing.
At least 3 years managing supplier quality or contract manufacturer oversight.
Deep knowledge of 21 CFR Part 111 and FDA Quality Agreement guidance.
Lead Auditor certification (ASQ CQA, NSF, Exemplar Global, or equivalent) preferred.
Mastery of root cause analysis tools and experience with eQMS platforms.
Responsibilities
Lead audits and risk assessments to qualify new contract manufacturers and suppliers.
Author, negotiate, and maintain Quality Agreements with external partners.
Conduct annual and 'for-cause' quality audits of external facilities.
Review batch production records and approve or reject finished batches.
Investigate out-of-specification results and manage change control requests.
Triage product complaints and ensure compliance with MedWatch reporting.
Serve as the primary quality interface during FDA inspections and third-party audits.
Benefits
Full-time position with opportunities for professional growth.
Collaborative work environment with cross-functional teams.
Engagement with external partners and industry leaders.
Chance to influence quality standards in dietary supplements and functional foods.
Full Job Description
Job Type
Full-time
Description
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.
Requirements
WHAT YOU'LL NEED (REQUIREMENTS):
Education: Bachelor's degree in a science discipline (Biology, Chemistry, Food Science, or related); Master's preferred.
Core Experience: Minimum 7 years of progressive Quality experience in dietary supplements, pharma, or regulated food manufacturing.
Specialized Focus: At least 3 years specifically managing supplier quality or contract manufacturer (CMO) oversight.
Regulations: Deep working knowledge of 21 CFR Part 111 and FDA Quality Agreement guidance.
Certifications: Lead Auditor certification (ASQ CQA, NSF, Exemplar Global, or equivalent) is strongly preferred.
Technical Skills: Mastery of root cause analysis tools (5-Why, Fishbone) and experience using an eQMS platform (e.g., MasterControl, Veeva, TrackWise).
PHYSICAL REQUIREMENTS:
Ability to travel by air and ground to contract manufacturing facilities up to 25% of working time.
Ability to wear required personal protective equipment (PPE) for extended periods on production floors, including non-slip footwear (boots), hair net, beard net (if applicable), and nitrile food-grade gloves.
Ability to stand or walk for prolonged periods on the production floor during audits and site visits.
Ability to lift up to 25 pounds occasionally.
Comfortable working near moving mechanical parts during site visits.
Vision requirements include distance vision, color vision, peripheral vision, depth perception, and the ability to focus.
