Manager, QA Floor Support

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 a cGMP site. Reporting to the VP of Quality, this role manages 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 strong state of control on the production floor. This position is fully onsite in Winston Salem, NC.

Team Leadership & Oversight

• Lead, 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 and weekly QA floor support schedules aligned with manufacturing activities
• Provide real-time QA presence on the manufacturing floor, including routine walkthroughs, observation of operations, and support during processing
• Reinforce GMP and cleanroom behaviours across operations
• 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 and 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 documentation including forms, logbooks, testing records, alarms, and kitting documentation
• Ensure quarantined materials are stored and managed appropriately post-manufacturing
• Author, review, and revise SOPs and quality procedures related to on-the-floor operations
• Support internal audits, regulatory inspections, and broader compliance initiatives

Cross-Functional Collaboration

• Work within a fast-paced, matrixed environment to align on quality expectations and operational priorities
• Participate in cross-functional quality teams and continuous improvement initiatives

Additional Responsibilities

• Maintain high standards for documentation, data integrity, and compliance across all QA-OTF activities
• Support additional quality activities as required

Education & Experience

• Bachelor’s degree in a scientific or related discipline
• 5+ years of QA experience in cGMP aseptic manufacturing, ideally with on-the-floor oversight
• Strong working knowledge of commercial GMP requirements for sterile manufacturing
• Familiarity with FDA, EU, and ICH regulatory expectations
• Strong organisational, analytical, and time management skills
• Effective communicator with strong attention to detail
• Ability to manage multiple priorities in a fast-paced environment
• Comfortable working cross-functionally with a collaborative approach
• Physically able to perform tasks requiring mobility and time in cleanroom environments

Please apply directly, or contact Hemish Ilangaratne for further details.