Principal Specialist, Quality Operations

Clutch Canada; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Liquidia seeks a Principal Specialist, Quality Operations to provide senior quality leadership across GxP operations, including manufacturing, QC, and quality systems. This role emphasizes independent judgment, risk-based thinking, and cross-functional collaboration.

You will drive investigations, change controls, and continuous improvement, mentoring colleagues and influencing quality strategy without formal people management responsibilities. Occasional cross-site travel may be required.

Qualifications

• B.S. degree in a scientific, engineering, or technical field.
• 12+ years in a cGMP pharmaceutical/combination product environment (8+ years for Master's; 5+ for Ph.D.).
• Strong cGMP/GDP documentation and technical writing skills.
• Experience leading complex investigations spanning multiple functions.
• Experience with root-cause analysis, risk assessment, and reportability.
• Experience reviewing change controls with risk assessment and validation impact.
• Cross-functional quality authority defining strategies and quality system improvements.
• Excellent analytical and written/oral communication skills.
• Ability to mentor peers without formal supervisory authority.
• Willingness to travel occasionally.

Responsibilities

• Provide senior-level quality support across GMP operations.
• Lead and support complex investigations and continuous improvement.
• Review and approve quality records and documentation.
• Partner with cross-functional teams to assess quality risks and implement initiatives.
• Support quality decision-making with scientific, technical, and compliance judgment.
• Develop and improve quality systems, processes, metrics.
• Identify trends and drive corrective actions.
• Serve as a subject matter expert and mentor quality colleagues.
• Represent Quality Operations on cross-functional teams and regulatory interactions.
• Support strategic quality and operational initiatives to enable business objectives.

Skills

cGMP knowledge

Quality assurance

Investigations

Root cause analysis

Change controls

Documentation

Technical writing

Cross-functional

Mentoring others

Analytical thinking

Education

B.S. degree in scientific/engineering/technical field

Master's degree (preferred)

Ph.D. (preferred)

Tools

QMS software

GxP systems

Job description

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.

• 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 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.