Senior Quality Operations Specialist - GxP & Compliance

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 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.