Liquidia Corporation · 1 week ago
Senior Quality Associate
Morrisville, NC
Full-time
Onsite
Senior Level
5+ years expLiquidia Corporation is dedicated to the discovery and development of novel therapies for patients in need. The Senior Quality Associate is responsible for managing core quality systems, ensuring compliance with regulatory requirements, and driving continuous improvement across the organization.
BiopharmaBiotechnologyHealth CareNanotechnologyTherapeutics
Responsibilities
Lead and manage deviation management processes, ensuring timely investigation, documentation, and closure of deviations
Oversee change control management, including evaluation, implementation, and verification of changes to processes and systems
Maintain robust document management practices, ensuring controlled documents are accurate, current, and compliant
Lead and manage CAPA (Corrective and Preventive Action) management and ensuring effectiveness of corrective actions
Coordinate and facilitate Quality Management Reviews, compiling metrics and presenting quality performance data
Manage inspection processes, including preparation, inspection risk management, execution, and follow-up for regulatory audits
Serve as system owner for electronic quality platforms (e.g., Veeva), ensuring proper configuration and compliance
Develop and revise SOPs, work instructions, and templates related to quality systems
Provide training and guidance to staff on quality systems, compliance requirements, and best practices
Conduct regular walk throughs of areas for inspection readiness and regulatory compliance
Qualification
Required
Bachelor's degree in a scientific, engineering, or related discipline
Minimum 5-7 years of experience in quality assurance within a regulated industry
Strong knowledge of quality systems: deviation management, change control, document management, CAPA, and inspection management
Experience with routine FDA regulatory inspections
Excellent organizational, communication, and leadership skills
Detail-oriented with a commitment to compliance and quality
In-depth knowledge of FDA regulations, as well as experience with international regulations and guidelines related to Quality Management Systems
In-depth knowledge of Quality principles, concepts, systems, industry practices, and standards in relation to document management, training, change control, deviations and corrective/preventive actions
In-depth understanding of Good Manufacturing Practices (GMP) and applicable regulatory expectations for documentation in the industry
Strong proficiency with electronic document management systems and Microsoft Office Suite (Word, Excel)
Excellent attention to detail, organizational skills, and ability to manage multiple priorities
Effective verbal and written communication skills; ability to interface across all levels of the organization
Proven ability to work both independently and collaboratively in a team environment
Preferred
Experience with electronic documentation platforms (e.g., Veeva)
Benefits
Medical
Dental
Vision
STD
LTD
401(k) Savings Retirement Plan
ESPP
Unlimited Paid Time Off
Company
Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company focused on the development and commercialization of products in pulmonary hypertension and other applications of its PRINT® Technology.
51-200 employees
H1B Sponsorship
Liquidia Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$533.4MKey Investors
HealthCare Royalty PartnersPatient Square CapitalSilicon Valley Bank
2025-06-23Post Ipo Debt· $50M
2024-09-11Post Ipo Equity· $67.5M
2024-01-04Post Ipo Equity· $75M
Leadership Team
Roger Jeffs
Chief Executive Officer
Mike Kaseta
Chief Financial Officer
Recent News
2026-01-07
New Enterprise Associates
2026-01-06
Company data provided by crunchbase