Quality Operations Lead, Pharma Manufacturing & Compliance

Regulatory Jobs; North Carolina; On-site; USD 120,000 - 170,000; Full time

Job summary

Regulatory Jobs is seeking a Quality Operations Manager to provide hands-on support for Manufacturing and Quality activities and to manage daily Quality Operations functions. The role ensures cGMP compliance for finished pharmaceuticals and APIs and collaborates with cross-functional teams to resolve issues and maintain inspection readiness.

You will lead investigations, author reports, and drive CAPAs across incident reports, deviations, customer complaints, and internal audits, while

Qualifications

• Bachelor’s Degree in a scientific discipline is required.
• Minimum seven (7) years in pharmaceutical manufacturing, QA, or related regulated industry.
• Two (2) years of supervisory or people-management experience preferred.

Responsibilities

• Manage day-to-day Quality Operations workload and provide on-the-floor quality support.
• Lead manufacturing investigations, document root cause, and drive CAPAs.
• Coordinate development batches, API synthesis, PPQ activities, and batch record reviews.
• Provide cGMP equipment oversight with calibration status and quality documentation.
• Prepare audit responses and assist with internal audit processes.

Skills

Quality assurance

cGMP

Investigations

Documentation

MS Word

Education

Bachelor's degree in science

7+ years pharma experience

Tools

MS Excel

MS Outlook

Job description

Regulatory Jobs is seeking a Quality Operations Manager to provide hands-on support for Manufacturing and Quality activities and to manage daily Quality Operations functions. The role ensures cGMP compliance for finished pharmaceuticals and APIs and collaborates with cross-functional teams to resolve issues and maintain inspection readiness.

You will lead investigations, author reports, and drive CAPAs across incident reports, deviations, customer complaints, and internal audits, while