Principal Specialist, Quality Operations

Liquidia•,

About The Position

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.

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.

Nice To Haves

Familiarity with combination products and device components, including applicable regulations (e.g., 21 CFR Part 4), design controls, and device history records.
Experience representing Quality during FDA or other regulatory authority inspections.
Experience developing or improving quality system procedures, metrics, or dashboards related to investigations, complaints, or change control.
ASQ certification (e.g., CQE, CQA) or Lean Six Sigma Green/Black Belt.
Experience mentoring or providing technical guidance to other quality professionals.

Responsibilities

Provide senior-level quality support and technical expertise across manufacturing, laboratory, quality systems, and other GMP operations.
Lead and support complex quality events, investigations, assessments, and continuous improvement activities.
Review and approve quality records and documentation in accordance with company procedures and regulatory requirements.
Partner with cross-functional teams to assess quality risks, resolve issues, and ensure effective implementation of quality-related initiatives.
Support quality decision-making by applying sound scientific, technical, and compliance-based judgment.
Contribute to the development, maintenance, and continuous improvement of quality systems, processes, procedures, and metrics.
Identify quality trends, emerging issues, and opportunities for improvement, and drive appropriate corrective and preventive actions.
Serve as a subject matter expert for quality and compliance matters, providing guidance and mentoring to colleagues across the organization.
Represent Quality Operations on cross-functional teams, governance forums, inspections, audits, and regulatory interactions as needed.
Support strategic quality and operational initiatives to enable business objectives while maintaining compliance and product quality.
Perform other duties as assigned.