Manufacturing Quality Manager

Job DescriptionJob Description

Exact Location is within a 30 mile radius of Biloxi, MS

Job Summary: The Manufacturing Quality Manager is responsible for the quality oversight of all manufacturing and packaging operations to ensure compliance with applicable regulations (21 CFR Part 210/211), internal quality standards, and customer expectations. This role is central to implementing and maintaining a compliant manufacturing environment in a fast-paced, plant-based setting, with a focus on continuous improvement, operational efficiency, and regulatory excellence.

Key Responsibilities:

-Provide quality oversight for all pharmaceutical manufacturing and packaging operations on-site.

-Supervise and lead QA staff responsible for line release, batch record review, and process validation activities.

-Manage incoming inspection and sampling of raw materials and packaging components.

-Own the SOP lifecycle, including review, approval, and biennial updates.

-Participate in the investigation and resolution of product quality issues and non-conformances.

-Oversee the issuance and approval of batch records, labels, specifications, and monographs.

-Manage product quarantine shipments, recall programs, and the pest control program.

-Audit internal manufacturing processes to ensure compliance and readiness for regulatory inspections.

-Oversee facility environmental monitoring, including temperature and humidity controls.

-Support the product stability program and provide quality support to cross-functional teams.

-Collaborate with the Senior Director of Quality on strategic initiatives and compliance goals.

Required Skills and Competencies:

-Strong leadership and team management capabilities, with experience leading QA personnel in a manufacturing environment.

-Deep understanding of cGMPs, particularly in OTC or pharmaceutical manufacturing.

-Excellent communication skills, both written and verbal.

-Highly organized, with strong attention to detail and the ability to manage multiple priorities under pressure.

-Proven ability to analyze data, manage quality systems (change control, deviations, CAPAs), and implement improvements.

-Experience conducting internal audits and supporting regulatory inspections.

Education and Experience Requirements:

-Bachelor’s degree in Chemistry, Biology, or a related scientific discipline (required).

-Minimum of 8 years’ experience in pharmaceutical or OTC manufacturing environments.

-Prior experience with liquid and solid oral dosage forms required.

-People management experience is required; must have led QA teams or operations personnel.

-Strong familiarity with FDA regulations and 21 CFR Part 210/211.

-Proficient in Microsoft Office and quality management systems (QMS platforms a plus).

Physical Requirements:

-Ability to walk, stand, and sit for 8 or more hours daily.

-Must be comfortable working in plant and production environments.

Open to relocation.  Sign on bonus offered