Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary arterial hypertension (PAH). We will continue to combine our proprietary, innovative PRINT Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

Job Summary
The Senior Quality Assurance (QA) Associate is a QA‑focused role responsible for ensuring all GMP activities across the site meet regulatory requirements, internal quality standards, and industry best practices. While the primary responsibility is Quality Assurance, this position will also provide oversight of Quality Control (QC) activities, ensuring QC data, laboratory practices, and testing operations support compliant and timely product release.

The Senior QA Associate partners closely with QC, Manufacturing, Engineering, and other cross-functional groups to proactively identify risks, resolve issues, and uphold a strong culture of quality across all GMP functions. Education and Experience

• BS degree in a life science, engineering, or other relevant technical discipline (e.g., Biology, Chemistry, Microbiology, Biochemistry, Chemical Engineering).
• 5+ years of progressive experience in a cGMP-regulated pharmaceutical, biotechnology, or medical device environment.
• Working knowledge of QC laboratory operations, including review and approval of QC data in support of batch disposition and understanding of OOS, OOE, and invalid assay processes.
• Proven experience managing the full lifecycle of deviations, OOS, CAPAs, change controls, and GMP documentation.

Knowledge, Skills, and Abilities

• Thorough knowledge of cGMP regulations, quality system requirements (including 21 CFR Parts 210/211 and applicable ICH guidance), data integrity principles, and risk-based decision making.
• Familiarity with internal and external audit and inspection processes, including regulatory authority inspections.
• Strong analytical and problem-solving skills, with the ability to identify quality risks, investigate issues, and recommend effective corrective and preventive actions.
• Demonstrated skill in prioritizing and managing multiple quality activities in a fast-paced GMP environment.
• Detail oriented with strong interpersonal, oral, and written communication skills.
• Ability to exercise sound judgement, appropriately escalate quality concerns to Quality Leadership, and work effectively with minimal supervision, while recognizing when alignment or escalation is required.
• Ability to interpret and apply procedures, regulations, and guidance documents to real-world manufacturing and laboratory scenarios.

• Provide comprehensive QA oversight across GMP operations including manufacturing floor activities and QC laboratory functions, ensuring compliance with regulatory requirements, internal procedures, and data integrity standards.
• Deliver end-to-end QA oversight of OOS, deviations, change controls, CAPAs, and document revisions.
• Provide real-time, on-the-floor QA support during manufacturing operations, addressing quality concerns and ensuring adherence to cGMP.
• Perform routine QA walkthroughs of all GMP areas to verify compliance, identify and address issues, and reinforce a culture of quality and operational excellence.
• Support the internal audit program and site inspection readiness and serve as a QA SME during internal and external inspections.
• Lead and contribute to cross-functional teams to identify and investigate quality issues, determine root causes, and implement effective corrective and preventive actions.
• Identify and drive process improvement initiatives that enhance product quality and operational efficiency.
• Monitor and report key quality metrics, escalating trends and issues to Quality Leadership as appropriate.
• Foster a culture of quality, transparency, and continuous improvement throughout the organization.