Mgr.-Quality, Health & Nutrition

Huber•Quincy, MA

1d•Onsite

About The Position

The Quality Manager – Nutrition leads all quality assurance and quality control activities for Huber Specialty Minerals’ Nutrition business in Quincy, IL. This role is critical to maintaining compliance with pharmaceutical and nutritional product regulations, ensuring adherence to cGMP requirements, Quality Management Systems (QMS), and customer expectations. The Quality Manager serves as the site quality leader, overseeing laboratory operations, audits, investigations, validation activities, and continuous improvement initiatives while partnering closely with Operations, Regulatory, and commercial teams to drive product quality, compliance, and business performance.

Requirements

Bachelor's degree in Chemistry, Food Science, Pharmaceutical Sciences, or related discipline; advanced degree preferred.
7–10 years of experience in regulated manufacturing environments with pharmaceutical cGMP experience strongly preferred ; food, nutrition, or dietary supplement experience also 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.
Proven 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

Experience in granulation processes is a plus.

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.