Senior Quality Operations Lead - Pharma GMP

Exela Pharma Sciences; British Woods (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Exela Pharma Sciences is seeking a Quality Operations Manager in Lenoir, NC to provide hands-on leadership for Manufacturing and Quality activities, ensuring cGMP compliance and driving investigations and batch execution.

The role collaborates across Manufacturing, Quality Control, Validation, Metrology, and other cross-functional teams to resolve quality issues, support API synthesis, and ensure inspection readiness.

Qualifications

• Bachelor’s degree in a scientific discipline required and a minimum of seven (7) years of experience in pharmaceutical manufacturing, quality assurance, quality operations, or a related regulated industry.

Responsibilities

• Manage day-to-day priorities, workload, and performance of Quality Operations personnel, while remaining involved in shop-floor quality support and escalation of quality events.
• Lead and perform manufacturing investigations, gather data, interview personnel, review batch and equipment records, write root-cause and investigation reports, and drive CAPAs.
• Provide hands-on quality support for Development Batches, API synthesis, and commercial manufacture, coordinating documentation and ensuring records are accurate and complete.
• Oversee cGMP equipment quality documentation, calibration status, and related records with Metrology, Maintenance, Validation, and Manufacturing.
• Support Internal Audit program by preparing audit responses, collecting evidence, and verifying completion of actions.
• Coach, train, and develop Quality Operations team to ensure compliance with cGMP expectations and documentation standards.
• Monitor open investigations, deviations, CAPAs, and batch-record quality activities to ensure timely completion and escalation of overdue items.

Skills

Technical writing

Math calculations

English literacy

Education

Bachelor’s Degree in a scientific discipline

Tools

MS Outlook

MS Word

MS Excel

Job description

Exela Pharma Sciences is seeking a Quality Operations Manager in Lenoir, NC to provide hands-on leadership for Manufacturing and Quality activities, ensuring cGMP compliance and driving investigations and batch execution.

The role collaborates across Manufacturing, Quality Control, Validation, Metrology, and other cross-functional teams to resolve quality issues, support API synthesis, and ensure inspection readiness.