Quality Manager - Health & Nutrition
About The Position
The Quality Manager leads all quality assurance and quality control activities for Huber Specialty Minerals’ Nutrition business in Quincy, Illinois. The role is the site quality leader, responsible for maintaining compliance with pharmaceutical and nutritional product regulations, cGMP requirements, quality management systems, and customer expectations. The manager oversees laboratory operations, audits, investigations, validation activities, and continuous improvement while partnering with Operations, Regulatory, and commercial teams to support product quality, compliance, and business performance. The position manages site quality programs and staff; laboratory testing, documentation, batch record review and product release; document and change control; CAPA, complaints, investigations, and out-of-specification processes; training; audits and inspections; APQR, environmental monitoring, stability and validation programs; and quality metrics. It also maintains the Validation Master Plan and supports continuous improvement, change management, and Cost of Poor Quality initiatives. Travel may be up to 15%.
Requirements
- Bachelor's degree in Chemistry, Food Science, Pharmaceutical Sciences, or a related discipline.
- 7–10 years of experience in regulated manufacturing environments; pharmaceutical cGMP experience is strongly preferred, and food, nutrition, or dietary supplement experience is valued.
- Minimum 4 years of quality leadership or supervisory experience.
- Demonstrated 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.
- Ability to lead cross-functional initiatives, manage complex investigations, and drive continuous improvement.
- Strong analytical, project management, communication, and customer-facing skills.
- Proficiency in Microsoft Office applications.
Nice To Haves
- Advanced degree.
- Experience in granulation processes.
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.
- Own site document control, change control, CAPA, customer complaints, root cause investigations, and out-of-specification processes.
- Lead customer audits, FDA inspections, third-party audits, and internal quality audits, and 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.
Benefits
- Comprehensive, competitive benefits package.
- May be eligible for an annual discretionary bonus and profit-sharing payout.
- Opportunities for professional and personal development.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
