Manager, QA Floor Support

Team Leadership & Oversight

• Manage, develop, and coach the QA On-the-Floor team; ensure training, qualification, and performance expectations are met.
• Assign and approve work performed by direct reports, including documentation reviews and floor support activities.
• Maintain team readiness by ensuring all OTF personnel remain gown-qualified and trained on current procedures.

Manufacturing Floor Support & Quality Oversight

• Oversee and publish daily/weekly QA floor support schedules aligned with the manufacturing schedule.
• Provide real-time QA presence on the manufacturing floor, including routine walkthroughs, observation of operations, support during processing, and reinforcement of cleanroom behaviors.
• Identify, document, and escalate GMP issues or atypical events during manufacturing.
• Perform and/or oversee real-time batch record review to ensure accuracy and completeness.

Quality Decision Making & Issue Resolution

• Make routine QA decisions related to room/equipment release, line clearance, and documentation accuracy.
• Support and/or approve alarms, return-to-service documentation, deviations, change controls, and other quality records related to floor operations.
• Partner with Manufacturing to troubleshoot operational issues and implement corrective actions.

Documentation & Compliance Activities

• Ensure timely review of GMP documents (forms, logbooks, testing documentation, alarms, kitting, etc.).
• Ensure quarantined materials are stored and managed appropriately post-manufacturing.
• Author, revise, and review SOPs and quality procedures related to on-the-floor operations.
• Support internal audits, regulatory inspections, and compliance initiatives.

Cross Functional Collaboration

• Collaborate in a fast-paced, matrixed environment to ensure alignment on quality expectations and operational priorities.
• Participate in cross-functional quality teams and process improvement initiatives.

Education And Experience

• Bachelor’s degree in applied science or related field.
• 5+ years relevant QA experience in cGMP, preferred as Quality on the floor.
• Proven, hands-on knowledge of commercial GMP regulations for sterile manufacturing.
• Strong organizational, analytical, and time management skills.
• Ability to work well in a team environment with positive attitude.
• Excellent communication skills with strong attention to detail.
• Ability to handle multiple tasks simultaneously.
• Demonstrated working knowledge of FDA, EU, and ICH regulatory requirements.
• Physical ability to perform frequent tasks requiring strength and mobility.