Quality Operations Lead - cGMP & Manufacturing

Exela Pharma Sciences LLC; North Carolina; On-site; USD 120,000 - 160,000; Full time

Job summary

Exela Pharma Sciences LLC is seeking a Quality Operations Manager to provide hands-on support for Manufacturing and Quality activities and to manage daily Quality Operations functions. You will ensure cGMP compliance for finished dosages and APIs, partnering with manufacturing, QC, validation, and metrology to resolve quality issues and drive investigations.

You will lead investigations, support development batches and PPQ activities, maintain documentation accuracy, and coach the Quality

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• Minimum 7 years of experience in pharmaceutical manufacturing, quality assurance, quality operations, or related regulated industry.
• Minimum 2 years of supervisory/leadership experience preferred.
• Must be able to read/write English and have technical writing skills.

Responsibilities

• Manage day-to-day Quality Operations priorities and personnel with hands-on shop-floor quality support.
• Lead manufacturing investigations, document root cause, and drive CAPAs for incidents, deviations, complaints, and internal audits.
• Coordinate documentation for development batches, API synthesis, PPQ batches, and batch record reconciliation.
• Oversee cGMP equipment calibration, records, logbooks, and related quality documentation.
• Support Internal Audit Program: prepare audit responses, collect objective evidence, and verify CAPA actions.

Education

Bachelor’s Degree in a scientific discipline

Tools

MS Outlook

MS Word

MS Excel

Job description

Exela Pharma Sciences LLC is seeking a Quality Operations Manager to provide hands-on support for Manufacturing and Quality activities and to manage daily Quality Operations functions. You will ensure cGMP compliance for finished dosages and APIs, partnering with manufacturing, QC, validation, and metrology to resolve quality issues and drive investigations.

You will lead investigations, support development batches and PPQ activities, maintain documentation accuracy, and coach the Quality