Quality Operations Lead – Pharma Manufacturing & Compliance

Exela Pharma Sciences, LLC; Lenoir (NC); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Exela Pharma Sciences, LLC is seeking a Quality Operations Manager in Lenoir, NC to provide hands-on support for manufacturing and quality activities and to manage daily Quality Operations functions. This role ensures cGMP compliance and partners cross-functionally to resolve quality issues and drive investigations.

The candidate will lead investigations, supervise QA personnel, coordinate documentation for development batches and PPQ activities, and maintain inspection readiness across QA,

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.
• A minimum of two (2) years of supervisory, team lead, or people management experience preferred.
• Must be able to read and write English, possess technical writing skills, perform mathematical calculations, write and follow scientific terminology and notation.

Responsibilities

• Manage day-to-day priorities, workload, and performance of Quality Operations personnel, while remaining directly involved in shop-floor quality support, issue resolution, documentation review, and escalation of quality events.
• Lead and perform manufacturing investigations, including gathering data, interviewing personnel, reviewing batch records and equipment records, documenting root cause, writing investigation reports, and driving timely CAPAs for incident reports, deviations, customer complaints, internal audit responses, and internal process observation responses.
• Provide hands-on Quality Operations support for development batches, API synthesis, commercial manufacturing, and PPQ activities by coordinating documentation and participating in production readiness activities, resolving real-time quality questions, and ensuring required records are accurate and complete.
• Provide hands-on oversight of cGMP equipment by partnering with Metrology, Maintenance, Validation, and Manufacturing to ensure calibration status, equipment records, logbooks, and related quality documentation are complete and compliant.
• Support manufacturing of commercial products by providing on-the-floor quality guidance, reviewing executed documentation, assessing documentation discrepancies, and escalating quality or compliance concerns when appropriate.
• Support the Internal Audit Program by preparing audit responses, collecting objective evidence, assisting with CAPA implementation, and verifying completion of assigned actions.
• Coach, train, and develop Quality Operations team members by reviewing work products, providing performance feedback, reinforcing cGMP expectations, and ensuring team members understand priorities, procedures, and documentation standards.

Skills

Quality operations

Supervisory experience

Technical writing

Attention to detail

English fluency

Education

Bachelor's degree in science

Tools

MS Outlook

MS Word

MS Excel

Job description

Exela Pharma Sciences, LLC is seeking a Quality Operations Manager in Lenoir, NC to provide hands-on support for manufacturing and quality activities and to manage daily Quality Operations functions. This role ensures cGMP compliance and partners cross-functionally to resolve quality issues and drive investigations.

The candidate will lead investigations, supervise QA personnel, coordinate documentation for development batches and PPQ activities, and maintain inspection readiness across QA,