Quality Manager
Listed on 2026-06-16
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist / Manager, Quality Control / Manager, Quality Technician/ Inspector
The Quality Manager will establish and build a Quality Management System (QMS) from the ground up and serve as the senior owner and single point of accountability for product quality, compliance, and continuous improvement across our supply chain. This is a hands‑on, high‑ownership role for someone who has built or significantly matured a QMS inside a VMS, dietary supplement, or consumer health manufacturing environment, and who is energized by working closely with contract manufacturers, third‑party labs, R&D, and operations to ship products that meet the highest cGMP and certification standards.
This role sits at the intersection of compliance discipline and operational pragmatism. You will set the standard, write the playbook, and partner cross‑functionally to make quality a competitive advantage.
KeyDuties & Responsibilities QMS & Documentation Ownership
- Establish, build, and continuously improve Quality Management System (QMS) from the ground up, including all Standard Operating Procedures (SOPs), policies, and supporting infrastructure.
- Establish and manage change control, deviation management, and Corrective and Preventive Action (CAPA) processes.
- Build a scalable documentation architecture that supports rapid product expansion without sacrificing rigor.
- Own all quality documentation, including batch records, Certificates of Analysis (COAs), and product specifications, ensuring audit‑readiness at all times.
- Conduct detailed batch documentation and testing review to approve, hold, or reject lots, guaranteeing compliance with cGMP (21 CFR Part 111) and applicable certification standards.
- Maintain inspection‑readiness for FDA, state regulators, and third‑party certifying bodies.
- Serve as the primary point of contact for third‑party labs (e.g., Light Labs) for testing plans, method validation, and data review.
- Manage ongoing compliance with certifications such as NSF Certified for Content, including annual audits, surveillance visits, and corrective actions.
- Evaluate and onboard new testing partners as the product portfolio grows.
- Partner with contract manufacturers to monitor product quality, yields, and trends, and drive accountability for performance against specifications.
- Lead quality investigations (consumer complaints, deviations, OOS results) and ensure corrective actions are implemented, verified, and documented.
- Conduct supplier and contract manufacturer qualification, audits, and ongoing performance management.
- Collaborate with R&D on new product scale‑up, specification development, and validation.
- Partner with Marketing and Legal on compliance language, structure / function claims, and labeling review.
- Use consumer feedback (CX) and complaint data to drive continuous process and product improvements.
- Act as the internal voice of quality and compliance in cross‑functional decision‑making.
$100,
Requirements / Skills- Experience:
5+ years of progressive Quality experience in VMS, dietary supplements, nutraceuticals, food, or consumer health manufacturing, with meaningful time spent owning a QMS. - Regulatory fluency:
Deep working knowledge of 21 CFR Part 111 (cGMP for dietary supplements), FSMA/21 CFR Part 117 where applicable, FTC labeling and claims requirements, and applicable state regulations. - Contract manufacturing experience:
Direct, hands‑on experience working with contract manufacturers (CMs / co‑mans) is strongly preferred. You know how to set quality expectations with external partners, audit them, and hold them accountable to specifications without owning the line yourself. - Manufacturing fluency:
Comfortable in the plant, on the floor, and in the data; able to translate observations into specifications, SOPs, and corrective actions. - Certifications experience:
Track record of owning and successfully closing certification audits (NSF, Informed Sport, USP, Organic, or similar). - Packaging & label regulatory expertise:
Regulatory expertise spanning product, label, and packaging compliance. Able to independently validate packaging and labeling against…
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