Quality Systems & Compliance Leader (BioPharma)

Smithfield Foods; Cincinnati (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading food manufacturer is seeking a Quality Systems and Standards Manager to oversee the Quality Management System (QMS) and ensure compliance with cGMP regulations. The ideal candidate will have a Bachelor's degree in a related field and at least 5 years of experience in quality assurance within the pharmaceutical or food manufacturing sectors. Responsibilities include continuous improvement of quality systems, coaching QA teams, and monitoring compliance with FDA and ICH regulations. Preferred qualifications include leadership experience and knowledge of digital QMS tools.

Qualifications

• 5+ years in relevant manufacturing experience or equivalent education.
• 2+ years in leadership/project management in API pharmaceutical cGMP manufacturing.
• Strong understanding of GMP application in pharmaceutical industry.

Responsibilities

• Serve as Site Owner of the Quality Management System.
• Lead continuous improvement activities.
• Provide coaching to enhance professional performance.

Skills

Leadership in project management

Regulatory standards knowledge

Analytical thinking

Bilingual communication (Mandarin and English)

Knowledge of data integrity principles

Education

Bachelor's degree in engineering, chemistry, or microbiology

Master’s degree in Science or Technical field

Tools

Digital QMS tools (TrackWise)

Job description

A leading food manufacturer is seeking a Quality Systems and Standards Manager to oversee the Quality Management System (QMS) and ensure compliance with cGMP regulations. The ideal candidate will have a Bachelor's degree in a related field and at least 5 years of experience in quality assurance within the pharmaceutical or food manufacturing sectors. Responsibilities include continuous improvement of quality systems, coaching QA teams, and monitoring compliance with FDA and ICH regulations. Preferred qualifications include leadership experience and knowledge of digital QMS tools.