Manager, Quality Operations

Education Requirements

• 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 Required.
• A minimum of two (2) years of supervisory, team lead, or people management experience Preferred.

1. 1Manage the 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.
   • Manufacturing/Quality Assurance Liaisons (MQAs)
   • Scientific/Quality Assurance Liaisons (SQAs)
   • Metrology Manager and Calibration Technician
   • QA Compliance Associate
2. 2Lead and perform manufacturing investigations, including gathering data, interviewing personnel as needed, reviewing batch records and equipment records, documenting root cause, writing investigation reports, and driving timely corrective and preventive actions for:
   • Incident Reports
   • Process Deviation Reports
   • Customer Complaints
   • Internal Audit Responses
   • Internal Process Observation Responses
3. 3Provide hands-on Quality Operations support for Development Batches, API Synthesis, commercial manufacturing, and PPQ activities by coordinating documentation, participating in production readiness activities, resolving real-time quality questions, and ensuring required records are accurate and complete, including:
   • MBR generation and/or revision
   • Maintenance of the Master Batch Record Revision Table
   • Lot number assignment
   • BPR issuance and reconciliation
   • Cross-functional coordination to plan, prepare, and execute development products and PPQ batches
   • Post-execution review of Batch Production Records
   • Preparation of documentation for API product disposition
   • Tracking and trending of Quality metrics
4. 4Provide 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.
5. 5Support 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.
6. 6Support the Internal Audit Program by preparing audit responses, collecting objective evidence, assisting with CAPA implementation, and verifying completion of assigned actions.
7. 7Performs other duties as assigned.
8. 8Coach, 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.
9. 9Monitor open investigations, deviations, CAPAs, audit responses, batch record reviews, and equipment-related quality activities to ensure timely completion and appropriate escalation of overdue or high-risk items.