Senior Quality 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 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.

The Senior Quality Associate is responsible for managing and overseeing core quality systems, including deviation management, change control management, document management, CAPA management, Quality Management Review (QMR), and inspection readiness. This role ensures compliance with regulatory requirements, internal standards, drives continuous improvement across the organization, and plays a critical part in maintaining the company’s inspection readiness and compliance posture.

• Lead and manage deviation management processes, ensuring timely investigation, documentation, and closure of deviations.
• Oversee change control management, including evaluation, implementation, and verification of changes to processes and systems.
• Maintain robust document management practices, ensuring controlled documents are accurate, current, and compliant.
• Lead and manage CAPA (Corrective and Preventive Action) management and ensuring effectiveness of corrective actions.
• Coordinate and facilitate Quality Management Reviews, compiling metrics and presenting quality performance data.
• Manage inspection processes, including preparation, inspection risk management, execution, and follow-up for regulatory audits.
• Serve as system owner for electronic quality platforms (e.g., Veeva), ensuring proper configuration and compliance.
• Develop and revise SOPs, work instructions, and templates related to quality systems.
• Provide training and guidance to staff on quality systems, compliance requirements, and best practices.
• Conduct regular walk throughs of areas for inspection readiness and regulatory compliance.

Education and Experience:

• Bachelor’s degree in a scientific, engineering, or related discipline.
• Minimum 5-7 years of experience in quality assurance within a regulated industry.
• Strong knowledge of quality systems: deviation management, change control, document management, CAPA, and inspection management.
• Experience with routine FDA regulatory inspections
• Experience with electronic documentation platforms (e.g., Veeva) preferred.
• Excellent organizational, communication, and leadership skills.
• Detail-oriented with a commitment to compliance and quality

Knowledge

Skills and Abilities:

• In-depth knowledge of FDA regulations, as well as experience with international regulations and guidelines related to Quality Management Systems.
• In-depth knowledge of Quality principles, concepts, systems, industry practices, and standards in relation to document management, training, change control, deviations and corrective/preventive actions.
• In-depth understanding of Good Manufacturing Practices (GMP) and applicable regulatory expectations for documentation in the industry.
• Strong proficiency with electronic document management systems and Microsoft Office Suite (Word, Excel).
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities.
• Effective verbal and written communication skills; ability to interface across all levels of the organization.
• Proven ability to work both independently and collaboratively in a team environment.

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

Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without…