Quality Manager, OFC

About the role

The Quality Manager – Gummy Dietary Supplement is responsible for ensuring compliance with FDA 21 CFR Part 111, food safety policies, and overseeing day-to-day production quality. This role also involves aligning operations with corporate quality policy, preparing for third-party audits, and ensuring adherence to dietary supplement cGMP.

Responsibilities

• Ensure compliance with Good Manufacturing Practices (21 CFR Part 111, 117, and 210/211) and food safety policies.
• Conduct in-line inspections within manufacturing and packaging areas across three shifts to meet customer specifications.
• Lead and manage the Quality Assurance and Quality Control departments, including hiring, training, scheduling, and performance management of quality personnel.
• Communicate and alert management of unusual occurrences and pertinent issues affecting production and packaging.
• Develop and maintain Standard Operating Procedures (SOPs) to support compliance with cGMP and regulatory standards.
• Monitor and maintain in-process testing equipment and troubleshoot as needed.
• Sample product components following MeriCal’s proper sampling technique and review corresponding production records.
• Generate and review Manufacturing Batch Release documentation, authorize product packaging release, and communicate product status to operations.
• Oversee and continuously improve the Quality Management System (QMS), including change control, corrective action plans (CAPAs), deviations, non-conformances, QA holds, complaints, product investigations, audits, and documentation control.
• Maintain a safe working environment by adhering to EHS, OSHA, and government regulations.
• Participate in and lead internal and external audits, including FDA, certification bodies, customers, and third-party audits.
• Collaborate with cross-functional teams to address quality issues and implement preventive actions.
• Monitor key quality metrics and trends, providing regular reports to senior leadership.
• Promote a strong quality culture focused on accountability, data integrity, and continuous improvement.
• Perform additional miscellaneous duties as assigned.

Requirements

• Minimum 5 years’ experience working in Quality environments for dietary supplements, confectionary, and/or food & beverage manufacturing.
• Familiarity with cGMP FDA requirements and regulations as they pertain to Quality in a dietary supplement manufacturing & packaging environment.
• Experience managing teams and implementing quality systems.
• Proven experience with internal and external audits.
• Computer literacy and proficiency with Microsoft Word, Excel, and other software necessary for the Quality Assurance Department.
• Attention to detail and ability to adapt to change in a fast-paced environment.
• Ability to read, write, and effectively communicate in English. Ability to communicate in Spanish is a plus.

Qualifications

• BS/BA degree in Engineering, Chemistry, Biology, or Food Science preferred.
• Relevant coursework and/or experience in lieu of education may be considered.
• 5 years of experience in Dietary Supplements / food manufacturing Quality Assurance role.