Senior Quality Assurance & Compliance Lead

Clutch Canada; United States; On-site; USD 70,000 - 110,000; Full time

Job summary

Liquidia is seeking a Senior Quality Associate to support core quality systems, including deviation management, change control, document management, CAPA, issuance, and quality system metrics. This role ensures GMP records are properly controlled and issued, contributing to regulatory compliance and inspection readiness.

Ideal candidates have a Bachelor’s in Life Sciences, 2+ years QA experience in a regulated environment, and familiarity with GMP principles and electronic documentation

Qualifications

• Bachelor’s degree in Life Sciences or related field; equivalent work experience may be considered.
• Minimum 2+ years of quality assurance experience in a regulated industry.
• Knowledge of deviation management, CAPA, change control, and document management.
• Experience with FDA inspections preferred; experience with electronic platforms preferred.

Responsibilities

• Maintain robust document management practices, ensuring controlled documents are accurate and current.
• Review and approve deviations, CAPAs, and change controls with root-cause analysis.
• Support day-to-day manufacturing and QC operations by issuing logbooks, forms, and batch records.
• Develop and revise SOPs, work instructions, and templates for quality systems.
• Support Management Review by compiling metrics and reporting quality trends.
• Provide training and guidance on quality systems and best practices.
• Identify quality risks, compliance gaps, and drive continuous improvement initiatives.
• Support inspection readiness activities and elevate risks to Quality Leadership.

Skills

Quality principles

GMP knowledge

EDMS experience

MS Office

Attention to detail

Communication skills

Team collaboration

Education

Bachelor’s degree in Life Sciences or related field

Tools

Veeva

Kneat

Job description

Liquidia is seeking a Senior Quality Associate to support core quality systems, including deviation management, change control, document management, CAPA, issuance, and quality system metrics. This role ensures GMP records are properly controlled and issued, contributing to regulatory compliance and inspection readiness.

Ideal candidates have a Bachelor’s in Life Sciences, 2+ years QA experience in a regulated environment, and familiarity with GMP principles and electronic documentation