Senior Quality Manager

Neogen Corporation • Lexington, KY

1d • Onsite

About The Position

Neogen is seeking a Senior Quality Manager to lead and develop the Quality Control team, ensuring timely and compliant product release. This role involves managing the on-site Quality Assurance team, overseeing batch record reviews, nonconformance documentation, and final product release. The Senior Quality Manager will maintain and execute core Quality Management System (QMS) processes, conduct internal audits, and ensure ISO 9001 certification. Collaboration with Operations, suppliers, and other departments is key, as is monitoring and reporting on quality KPIs. This position offers opportunities for professional development in quality management and regulatory standards within a supportive work environment.

Requirements

• Degree in Biology, Chemistry, or a related scientific discipline from an accredited university.
• Previous experience in laboratory or manufacturing environments.
• Prior experience in people management.

Nice To Haves

• A minimum of 5 years’ experience in a quality role is preferred.
• Green Belt certification.
• ASQ Certified Quality Engineer.
• Experience conducting audits and working within ISO 9001‑certified manufacturing environments.
• Experience in microbiology or food safety laboratory settings.
• Able to work cross functionally and promote quality culture.
• Ability to prioritize and manage workload effectively while meeting deadlines.
• Excellent communication skills and the ability to collaborate with colleagues at all levels.

Responsibilities

• Lead and develop the Quality Control team to ensure timely and compliant product release.
• Manage the on‑site Quality Assurance team, ensuring batch record reviews, nonconformance documentation, and related activities are completed accurately and on schedule.
• Oversee final product release, including review and approval of analytical data, Certificates of Analysis (CoAs), and product labelling to ensure compliance with internal and external standards.
• Maintain and execute core Quality Management System (QMS) processes, including CAPAs, investigations, complaints, and change controls.
• Conduct thorough root cause analyses and drive continuous improvement initiatives across the site.
• Perform internal process audits according to the audit schedule, contributing to audit reports and ensuring timely follow‑up of corrective actions.
• Maintain ISO 9001 certification and lead the site through client, regulatory, and certification audits.
• Partner with Operations to ensure effective implementation and verification of corrective actions for non‑conformances.
• Work with suppliers to establish and maintain quality agreements, conduct supplier audits, and manage supplier corrective action requests.
• Maintain and report monthly KPIs from the electronic QMS, including trend analysis of nonconformities, complaints, and other quality indicators.

Benefits

• Opportunities to develop your expertise in quality management and regulatory standards, including exposure to ISO 9001.
• Hands‑on experience with a structured QMS and involvement in a broad range of quality activities, from investigations to audits and product release.
• A professional and supportive working environment where your contribution to maintaining high quality standards is recognised and valued.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior