Principal Specialist, Quality Operations

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 Principal Specialist, Quality Operations is a senior individual contributor within Quality Assurance who provides advanced quality, compliance, and technical leadership across Liquidia's GxP operations. This role serves as a key quality partner supporting manufacturing, quality control, product quality, quality systems, and other operational functions to ensure compliance with regulatory requirements and company quality standards.

This position is expected to operate with a high degree of independence, sound judgment, and a risk-based mindset while addressing a broad range of quality and operational challenges. As a recognized subject matter expert, the Principal Specialist leads and supports complex quality activities, drives continuous improvement initiatives, contributes to strategic quality objectives, and provides technical guidance across the organization.

The role is well suited for a hands‑on quality professional who thrives in a dynamic environment, is comfortable wearing multiple hats, and can effectively balance day‑to‑day operational support with longer‑term quality and compliance initiatives. While the position does not include formal people management responsibilities, it requires significant influence, collaboration, and mentorship across functions.

Job requirements:

• B.S. degree in a scientific, engineering, or technical field.
• 12+ years of relevant experience in a cGMP pharmaceutical or combination product manufacturing environment (Master's degree, 8+ years; Ph.D., 5+ years), with a preference for quality assurance support functions.
• Strong cGMP/GDP documentation and technical writing skills.
• Demonstrated experience independently leading, reviewing, or approving highly complex investigations spanning multiple functions (e.g., Manufacturing, QC) with ambiguous or systemic root causes.
• Demonstrated experience writing and/or reviewing product complaint investigations, including root cause analysis, risk assessment, and reportability considerations.
• Demonstrated experience reviewing and helping strategize complex change controls, including risk assessment and validation/qualification impact evaluation.
• Recognized as a cross‑functional quality authority capable of defining quality strategies, interpreting evolving GMP expectations, and driving quality system improvements across functions.
• Excellent analytical and critical thinking skills, with the ability to synthesize trends across deviations, complaints, and change controls to identify systemic issues.
• Excellent oral and written communication skills, including experience representing Quality in cross‑functional settings.
• Demonstrated ability to mentor and influence peers and other quality professionals through technical expertise rather than formal supervisory authority.
• Ability to work effectively in a fast‑paced, entrepreneurial environment.
• Occasional travel may be requested for cross‑site meetings or training; regular travel is not a routine requirement of this role.

Preferred Experience:

• Familiarity with combination products…