Quality Operations Leader — Pharma Compliance

RXinsider LTD.; Columbus (OH); On-site; USD 85,000 - 115,000; Full time

Job summary

Safecor Health is seeking a Quality Supervisor to lead day-to-day quality operations, including inspections, deviations, and controlled substance documentation. You will coach quality staff and partner with operations to ensure production meets FDA, DEA, and cGMP standards.

The role emphasizes accountability, teamwork, and continuous improvement within a fast-paced pharmaceutical environment. Strong leadership and meticulous documentation are essential for success.

Qualifications

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

Responsibilities

• Provide daily direction, coaching, and feedback to quality staff, fostering professional growth and accountability.
• Train and mentor new employees on quality procedures, compliance, and best practices.
• Promote a safe, compliant, and inclusive environment, ensuring adherence to OSHA and company safety requirements.
• Oversee in-process and final inspections to ensure products meet quality specifications and cGMP requirements.
• Manage deviations, incident reports, and audits, including investigation, documentation, and closure.
• Ensure accurate documentation and recordkeeping for all controlled substances, DEA 222 forms, ARCOS reporting, and product destruction activities.
• Support regulatory inspections and customer audits with professionalism and thorough preparation.
• Ensure labeling accuracy and oversee creation and revision of drug and packaging labels.
• Partner with operations supervisors and pharmacists to align on production and quality goals.
• Work closely with operations to ensure inspection procedures are implemented, documented, and maintained.
• Serve as a point of contact for drug manufacturers to gather product-specific information.
• Facilitate clear, timely, and concise communication across teams and with customers.

Skills

Leadership

Interpersonal skills

Organizational skills

Microsoft Office

SharePoint

Communication

Multitasking

Education

Bachelor's degree in science

Tools

Microsoft Office Suite

SharePoint

Job description

Safecor Health is seeking a Quality Supervisor to lead day-to-day quality operations, including inspections, deviations, and controlled substance documentation. You will coach quality staff and partner with operations to ensure production meets FDA, DEA, and cGMP standards.

The role emphasizes accountability, teamwork, and continuous improvement within a fast-paced pharmaceutical environment. Strong leadership and meticulous documentation are essential for success.