Position Summary
The Quality Operations Manager provides hands-on support for Manufacturing and Quality activities and directly manages daily Quality Operations functions. This position supports the Quality Systems within the Quality Assurance Unit by ensuring cGMP compliance for finished pharmaceuticals and Active Pharmaceutical Ingredients (API), actively partnering with Manufacturing, Quality Control, Validation, Metrology, and other cross-functional teams to resolve quality issues, drive investigations, support batch execution, and maintain inspection readiness.
Job Responsibilities
- Manage 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
- Lead 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
- Provide 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
- 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.
- Performs other duties as assigned.
- 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.
- Monitor 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.
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.
Experience Requirements
- Must be able to read and write English, possess technical writing skills, perform mathematical calculations, write and follow scientific terminology and notation.
- Must be able to follow instructions, attend to details, multi-task, and handle multiple priorities without undue stress or errors.
- Must have computer skills including MS Outlook, and be proficient using MS Word and MS Excel.
- Must be able to sit and/or stand for extended periods of time,
- Must be able to climb stairs, must be able to lift and carry 25 lbs, and walk while carrying items
- Must be able to see very small print and tiny graduations.
