Director Quality & Compliance

Hartmann Young; California (MO); On-site; USD 150,000 - 230,000; Full time

Job summary

Hartmann Young seeks a hands-on Head of Quality and Compliance to lead QA, QC 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, including

Qualifications

• 8+ years of quality leadership in regulated manufacturing (dietary supplements, nutraceuticals, food or OTC).
• Strong knowledge of FDA dietary-supplement cGMP requirements (21 CFR Part 111).
• Experience leading FDA and customer audits, investigations, CAPA and quality-system improvements.

Responsibilities

• Lead 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.
• Serve as senior quality contact for FDA inspections, customer audits and third-party certification bodies.
• Ensure testing, specifications and release procedures for raw materials, in-process and finished products.
• Partner with Regulatory, R&D, Operations and Commercial teams for 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 labeling support.

Skills

Quality leadership

Regulatory compliance

FDA audits

CAPA management

QMS optimization

Cross-functional leadership

Education

Bachelor's in Science

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.