Quality Manager, Dietary Supplements & Functional Foods

Blueroot Health®; Middletown (CT); On-site; USD 110,000 - 150,000; Full time

Job summary

Blueroot Health is seeking a Quality Manager (Dietary Supplements & Functional Foods) to ensure products from contract manufacturers comply with 21 CFR Part 111 and internal quality standards. You will own supplier qualification, quality agreements, audits, batch review, CAPA, and cross‑functional collaboration with R&D, regulatory, and operations.

In this role you will drive quality improvements across in‑house and external manufacturing, support inspections, and maintain a unified quality

Qualifications

• Bachelor’s degree in a science discipline; Master’s preferred.
• 7+ years of Quality experience in dietary supplements, pharma, or regulated foods.
• 3+ years managing supplier quality or contract manufacturing (CMO) oversight.
• Deep working knowledge of 21 CFR Part 111 and FDA Quality Agreement guidance.
• Lead Auditor certification (ASQ CQA, NSF, Exemplar Global, or equivalent) strongly preferred.
• Experience with root cause analysis tools (5-Why, Fishbone) and eQMS platforms.

Responsibilities

• Partner Qualification: Lead audits and risk assessments to qualify and tier new CMOs and raw material suppliers.
• Quality Agreements: Author, negotiate, and maintain legally binding Quality Agreements with all external partners.
• On‑Site Audits: Conduct annual and for‑cause audits of external facilities; track corrective actions and supplier scorecards.
• Batch Disposition: Review batch records and COAs to approve or reject finished batches prior to release.
• Deviations & CAPA: Investigate OOS results, manage external change control requests, and drive root cause analysis with partners.
• Complaints & Adverse Events: Triage product complaints, lead investigations, and ensure regulatory reporting.
• Regulatory Representation: Interface during FDA inspections, NSF/USP certifications, and third‑party audits.

Skills

Quality management

Supplier quality

Contract manufacturing oversight

FDA regulations

Root cause analysis

eQMS familiarity

Education

Bachelor’s degree in science

Master’s preferred

Tools

MasterControl

Veeva

TrackWise

Job description

Blueroot Health is seeking a Quality Manager (Dietary Supplements & Functional Foods) to ensure products from contract manufacturers comply with 21 CFR Part 111 and internal quality standards. You will own supplier qualification, quality agreements, audits, batch review, CAPA, and cross‑functional collaboration with R&D, regulatory, and operations.

In this role you will drive quality improvements across in‑house and external manufacturing, support inspections, and maintain a unified quality