Quality Operations Leader – FDA/cGMP Compliance

Safecor Health; Columbus (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

Safecor Health in Columbus, Ohio seeks a Quality Supervisor to lead daily quality operations, oversee in-process and final inspections, manage deviations and audits, and maintain controlled substance documentation. You will coach staff and collaborate with operations to meet regulatory and company standards.

You will ensure cGMP compliance, OSHA safety, and successful regulatory inspections, while fostering accountability and continuous improvement across the quality function.

Qualifications

• Bachelor’s degree in a science-related field.
• 3+ years of pharmaceutical industry experience or equivalent cGMP experience in quality.
• Supervisory or lead-level experience preferred.
• Quality experience within an FDA-regulated facility required.
• Experience with controlled substance regulations and repackaging medications is strongly preferred.

Responsibilities

• Oversee day-to-day quality operations including inspections and documentation.
• Lead, coach, and develop quality staff across the function.
• Manage deviations, incident reports, and audits with proper investigations and closure.
• Ensure accurate documentation for controlled substances, DEA 222 forms, ARCOS reporting, and destruction activities.
• Collaborate with operations to align on production and quality goals and support regulatory inspections.

Skills

Leadership

Regulatory knowledge

Communication

Documentation

Team coaching

Education

Bachelor's degree in science

Tools

Microsoft Office

SharePoint

Job description

Safecor Health in Columbus, Ohio seeks a Quality Supervisor to lead daily quality operations, oversee in-process and final inspections, manage deviations and audits, and maintain controlled substance documentation. You will coach staff and collaborate with operations to meet regulatory and company standards.

You will ensure cGMP compliance, OSHA safety, and successful regulatory inspections, while fostering accountability and continuous improvement across the quality function.