Sr. Manager, Quality Operations

Liquidia

3d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

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.

Responsibilities

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.