Quality Leader - Health & Nutrition, cGMP Expert

J.M. Huber Corporation; Quincy (IL); On-site; USD 97,000 - 126,000; Full time

Job summary

J.M. Huber Corporation in Quincy, IL seeks a Quality Manager – Nutrition to lead QA/QC, oversee laboratory operations, audits, and CAPA activities, and ensure cGMP compliance for the Nutrition business.

You will drive continuous improvement and partner with Operations and Regulatory teams to uphold product quality and regulatory standards. The role requires 7–10 years in regulated manufacturing with pharmaceutical cGMP experience, plus 4+ years of quality leadership, and travel up to 15%.

Qualifications

• Bachelor's degree in Chemistry, Food Science, Pharmaceutical Sciences, or related discipline; advanced degree preferred.
• 7–10 years in regulated manufacturing with pharmaceutical cGMP experience strongly preferred; food, nutrition, or dietary supplement experience valued.
• Minimum 4 years of quality leadership or supervisory experience.
• Experience leading FDA inspections, regulatory audits, customer audits, and remediation activities.
• Strong knowledge of cGMP requirements, validation programs, quality systems, CAPA, change control, and risk management.
• Experience with ICH-Q7, 21 CFR Part 111, 21 CFR Part 117, HACCP, and quality management systems.
• Proven ability to lead cross-functional initiatives, manage complex investigations, and drive continuous improvement.
• Strong analytical, project management, communication, and customer-facing skills.
• Experience in granulation processes is a plus. Proficiency in Microsoft Office applications; travel up to 15%.

Responsibilities

• Lead site quality programs and ensure compliance with applicable cGMP, QMS, and regulatory requirements, including ICH-Q7, 21 CFR 111, and 21 CFR 117.
• Manage day-to-day Quality Assurance and Quality Control activities, including laboratory testing, documentation review, batch record approval, and product release decisions.
• Supervise and develop Quality staff to support operational excellence and compliance objectives.
• Own site document control, change control, CAPA, customer complaints, root cause investigations, and out-of-specification (OOS) processes.
• Lead customer audits, FDA inspections, third-party audits, and internal quality audits; drive corrective and preventive actions to closure.
• Direct training programs related to cGMP, QMS, HACCP, and quality procedures while maintaining training compliance records.
• Oversee Annual Product Quality Reviews (APQR), environmental monitoring, stability programs, validation activities, and Quality metrics.
• Maintain and execute the Validation Master Plan (VMP), including process, cleaning, product, and system validations.
• Partner with Operations and leadership teams to drive continuous improvement, change management, and Cost of Poor Quality initiatives.
• Ensure timely issuance of Certificates of Analysis (CoAs), customer documentation, and quality-related communications.

Skills

Quality leadership

Regulatory audits

FDA inspections

cGMP

CAPA

Risk management

Cross-functional collaboration

Analytical skills

Project management

Communication skills

Education

Bachelor's in Chemistry/Pharmaceutical Sciences

Tools

Microsoft Office

Job description

J.M. Huber Corporation in Quincy, IL seeks a Quality Manager – Nutrition to lead QA/QC, oversee laboratory operations, audits, and CAPA activities, and ensure cGMP compliance for the Nutrition business.

You will drive continuous improvement and partner with Operations and Regulatory teams to uphold product quality and regulatory standards. The role requires 7–10 years in regulated manufacturing with pharmaceutical cGMP experience, plus 4+ years of quality leadership, and travel up to 15%.