Senior QA Operations Associate

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 hypertension (PH). 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) Operations Associate plays a critical role in ensuring that all Good Manufacturing Practice (GMP) activities at the site are performed according to regulatory standards, company policies, and industry best practices. This role involves direct oversight of quality assurance activities on the manufacturing floor, batch record review, deviation management, change control, and real-time problem-solving. The Senior Quality Associate will work closely with cross-functional teams to maintain high quality standards and ensure the timely release of products.

This position requires thorough knowledge of QA operations and a proactive mindset dedicated to upholding product quality, safety, and compliance across all GMP areas.

Responsibilities

• Conduct comprehensive reviews of executed batch manufacturing and packaging records to ensure compliance with cGMP regulations and company policies.
• Provide on-the-floor QA support during manufacturing operations, proactively addressing and resolving quality-related issues in real time.
• Deliver end-to-end QA oversight for deviations, CAPAs, and change controls, including investigation, documentation, and final approval, ensuring alignment with GMP and internal standards.
• Support site inspection readiness and serve as a QA SME during internal and external inspections.
• Perform routine QA walkthroughs of all GMP areas to verify compliance, identify and address issues, and reinforce a culture of quality and operational excellence.
• Review and approve GMP documentation, including SOPs, batch records, and QC data.
• 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.

Requirements

Education and Experience

• Bachelor’s degree in a life science, engineering, or related field.
• Minimum of 7 years of experience in a quality assurance role within a pharmaceutical, biotechnology, or related industry, with at least 2 years in a senior or lead position.
• QC Experience highly preferred
• Experience in support of regulatory inspections preferred.

Knowledge, Skills, and Abilities

• In-depth understanding of United States Code of Federal Regulations, ICH Guidelines, and other local government regulatory requirements governing clinical and commercial manufacturing.
• Extensive knowledge and application of ALCOA+ standard, GMP, Good Documentation Practice, and International Council for Harmonization guidelines.
• Ability to lead and effectively participate in cross-functional and multi-disciplinary teams, independently prioritize work, manage multiple projects while maintaining quality, and advocate for quality risk management and regulatory compliance. Highly diplomatic and tactful with exceptional critical reasoning skills.
• Excellent problem-solving, critical thinking, and decision-making skills. Strong leadership and communication abilities. Proficiency in using quality management systems and electronic documentation systems.
• Detail-oriented, well-organized, and able to work effectively in a fast-paced, dynamic environment. Ability to lead and motivate cross-functional teams and manage multiple projects simultaneously.

Benefits

Liquidia offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, and more!

Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

Recruiting Agencies, Please Note:

Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.