Position Summary:

The Quality Assurance On-The-Floor (OTF) Manager is responsible for leading the QA On-The-Floor team and providing real-time quality oversight of clinical and commercial manufacturing activities at ProKidneys cGMP site. Reporting to the VP of Quality, this role managers daily floor support operations, ensures compliance with GMP and regulatory requirements, and partners closely with Manufacturing, Quality Control, Supply Chain, and Facilities to maintain a state of control on the production floor.

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.

Other Responsibilities

• Maintain standards for accurate documentation, data integrity, and compliance in all QA-OTF activities.
• Perform other duties as assigned.
• Education And Experience:
• Bachelors degree in applied science or related field.
• 5+ years relevant QA experience in cGMP aseptic manufacturing, 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.