Job Summary
The Sr. Manager, Quality Operations is a key member of the site Quality team, reporting to the Sr. Director, Quality Assurance. This role is responsible for the day-to-day operational quality activities that directly support manufacturing at Liquidia, including on-the-floor manufacturing support, batch record review, deviation and CAPA review and approval, change control review and approval, and batch disposition. The Sr. Manager oversees a team of Quality Associates and Sr. Associates and serves as a quality signatory for lot release.

The ideal candidate will have a strong operational quality background in a GMP manufacturing environment with direct experience in batch disposition, quality investigations, and shop-floor quality support. This role will be instrumental in building out Liquidia's real-time, on-the-floor quality presence as manufacturing operations continue to grow. Education and Experience

• Bachelor's degree in a scientific, engineering, or related discipline.
• Minimum 8 years of experience in Quality Assurance, Quality Operations, or a related GMP function in the pharmaceutical or biotechnology industry.
• Minimum 3 years of direct people management experience, including hiring, coaching, and performance management.
• Experience with batch record review, batch disposition, and lot release in a GMP manufacturing environment.
• Experience reviewing and approving deviations, CAPAs, and change controls.
• Experience supporting or hosting FDA inspections in a manufacturing or quality operations setting.

Preferred Experience

• Experience implementing or operating a real-time, on-the-floor quality support model (person-in-plant or QA-on-the-floor) in a GMP manufacturing environment.
• Experience with electronic quality management systems (eQMS) such as Veeva Vault QMS, TrackWise, or similar.

Knowledge, Skills and Abilities

• Strong knowledge of cGMP regulations (21 CFR Parts 210, 211), FDA expectations, and relevant ICH guidelines.
• Solid understanding of data integrity principles and their application to batch records, quality system documentation, and electronic records.
• Strong organizational skills with the ability to manage competing priorities across manufacturing support, batch review, and quality system activities.
• Effective written and verbal communication skills with the ability to work cross-functionally across Manufacturing, QC, Engineering, Regulatory, and Supply Chain.
• Ability to author, review, and approve SOPs, deviation reports, CAPA records, and change controls.
• Ability to make sound, risk-based quality decisions in real time on the manufacturing floor.

• Lead, mentor, and develop a team of Quality Associates supporting manufacturing quality operations.
• Provide on-the-floor quality support during manufacturing operations, including GMP guidance, line clearance, room and equipment release, and real-time quality decision-making.
• Develop and implement a real-time, on-the-floor quality support model to strengthen compliance and responsiveness during production.
• Review and approve batch production records for accuracy, completeness, and compliance with cGMP requirements and internal procedures.
• Serve as a quality signatory for batch disposition and lot release.
• Review and approve deviations, CAPAs, and change controls, ensuring thorough root cause analysis and timely closure.
• Perform GMP compliance walkthroughs of manufacturing, warehouse, and supporting areas and address observations proactively.
• Monitor and drive timely closure of quality records to support batch disposition timelines and overall quality system health.
• Collaborate with Manufacturing, Quality Control, Process Engineering, and Supply Chain, to resolve quality issues and support production schedules.
• Support inspection readiness activities and serve as a Quality Operations representative during FDA and other regulatory inspections, including back-room support and direct interaction with investigators.
• Identify risks, compliance gaps, and opportunities for improvement within Quality Operations and lead continuous improvement initiatives.
• Ensure all Quality Operations activities comply with cGMP requirements, data integrity expectations, and Liquidia internal procedures.
• Perform other duties as assigned.