Quality Leader – Nutrition & GMP Compliance

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 and QC for the Nutrition business, ensuring cGMP, QMS, and regulatory compliance.

You will oversee labs, audits, investigations, validation activities, and continuous improvement with Operations, Regulatory, and commercial teams. Requirements include a Bachelor’s in Chemistry, Food Science, or Pharmaceutical Sciences, and 7–10 years in regulated manufacturing with pharma cGMP; 4+ years in quality leadership.

Qualifications

• Bachelor’s degree in Chemistry, Food Science, or Pharmaceutical Sciences; advanced degree preferred.
• 7–10 years in regulated manufacturing with pharma cGMP experience preferred; nutrition or dietary supplement experience valued.
• Minimum 4 years of quality leadership or supervisory experience.
• Proven experience leading FDA inspections, regulatory audits, and remediation activities.
• Strong knowledge of cGMP, validation, QMS, 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 and drive continuous improvement.
• Strong analytical, project management, communication, and customer-facing skills.
• Experience in granulation processes is a plus.

Responsibilities

• Lead site quality programs and ensure compliance with cGMP, QMS, and regulatory requirements.
• Oversee QA/QC activities including laboratory testing, documentation review, batch release, 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 OOS processes.
• Lead customer audits, FDA inspections, third-party audits, and internal quality audits; drive CAPA closure.
• Direct training programs related to cGMP, QMS, HACCP, and quality procedures while maintaining training records.
• Oversee APQR, environmental monitoring, stability programs, validation activities, and Quality metrics.
• Maintain and execute the Validation Master Plan including process, cleaning, product, and system validations.
• Partner with Operations to drive continuous improvement, change management, and Cost of Poor Quality initiatives.
• Ensure timely issuance of Certificates of Analysis (CoAs) and quality-related communications.

Skills

pharma cGMP

regulatory audits

CAPA

quality leadership

investigations

data analysis

communication

project management

cross-functional

granulation

Education

Bachelor’s in Chemistry/ Food Science/ Pharmaceutical Sciences

Advanced degree preferred

Tools

Microsoft Office

Job description

J.M. Huber Corporation in Quincy, IL, seeks a Quality Manager – Nutrition to lead QA and QC for the Nutrition business, ensuring cGMP, QMS, and regulatory compliance.

You will oversee labs, audits, investigations, validation activities, and continuous improvement with Operations, Regulatory, and commercial teams. Requirements include a Bachelor’s in Chemistry, Food Science, or Pharmaceutical Sciences, and 7–10 years in regulated manufacturing with pharma cGMP; 4+ years in quality leadership.