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Hartmann Young

Director Quality & Compliance

california, MO

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Job description

We are seeking a hands-on Head of Quality and Compliance to lead Quality Assurance, Quality Control and regulatory compliance for a growing dietary-supplement CMO.

You will own the site quality management system, ensuring full compliance with FDA 21 CFR Part 111, cGMP, DSHEA and customer requirements. This is a highly visible leadership role, responsible for audit readiness, supplier quality, CAPA, change control, product release and building a proactive quality culture across the business.

Key responsibilities

Lead the QA, QC and compliance teams across manufacturing, laboratory and warehousing.

Own and continuously improve the QMS, including deviations, CAPA, complaints, change control, document control and training.

Act as the senior quality contact for FDA inspections, customer audits and third-party certification bodies.

Ensure appropriate raw-material, in-process and finished-product testing, specifications and release procedures.

Partner with Regulatory, R&D, Operations and Commercial teams to support compliant product launches and claims.

Strengthen supplier qualification, risk assessment and contract-manufacturing oversight.

Oversee California-market compliance considerations, including Proposition 65 risk assessment and labelling support where relevant.

Develop a strong, commercially minded quality culture that enables growth without compromising standards.

About you

8+ years’ quality leadership experience within dietary supplements, nutraceuticals, food, OTC or a similarly regulated manufacturing environment.

Strong working knowledge of FDA dietary-supplement cGMP requirements, particularly 21 CFR Part 111.

Proven experience leading FDA and customer audits, investigations, CAPA and quality-system improvement.

A confident people leader who can influence operations and senior stakeholders.

Degree in a relevant scientific, food science or technical discipline preferred.

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Worksite address

california, MO, 65018, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.

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