Liquidia Corporation · 2 weeks ago
Senior Validation Manager
Morrisville, NC
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expLiquidia Corporation is dedicated to developing innovative therapies for patients with pulmonary arterial hypertension. The Senior Validation Manager will oversee validation functions, collaborating with various teams to ensure compliance and effective operation of manufacturing processes throughout the product lifecycle.
BiopharmaBiotechnologyHealth CareNanotechnologyTherapeutics
Responsibilities
Guide and support the validation team to ensure that all projects are completed compliantly and on schedule
Represent validation cross functionally ensuring clear communication, providing strategy, and setting goals and objectives for the validation team
Project management skillset to remove roadblocks and communication clearly across all parties/ teams
Responsible for qualification activities to ensure Liquidia’s facilities, utilities, and equipment are built, installed, and operate as intended throughout their lifecycle
Author or review user requirements, design specifications, or functional specifications
Lead or participate in risk assessments related to commissioning, qualification, and validation activities
Design and execute detailed master plans and protocols, author traceability matrices, and summarize results in technical reports
Support Computer Systems Validation ensuring compliance with FDA, 21CFR Part 11, Eudra Volume 4: Anex 11, and ISPE GAMP 5 guidelines
Data Integrity: Ensuring accuracy, completeness, and consistency of the data to comply with regulatory standards and industry best practices
Audit Support: Supporting internal audit readiness by providing necessary documentation and responding to audit inquiries
Carry out investigations related to protocol discrepancies or deviations
Qualification
Required
Educational Background: BS/MS/MEng in a technical discipline
A minimum of 10 years' experience in commissioning, qualification, validation work, and CSV within FDA-regulated fields such as pharmaceuticals, biologics, or medical devices. Experience may include development, manufacturing, or quality
3+ years of validation management experience required
Technical and management experience to lead a dynamic validation group that supports internal and external manufacturing
Demonstrated aptitude for 'hands-on' protocol execution across a wide range of equipment and systems
Working knowledge of quality management system elements, including change control, deviation management, and corrective and preventive actions
Ability to work and communicate effectively within a cross-functional team and across levels within an organization
Ability to summarize data and results for business and technical audiences with excellent communication skills
Preferred
Experience with computerized system validation preferred
Mechanical aptitude and familiarity with production equipment, including automated systems
Experience with leading or supporting projects from late-stage product development through commercial launch preferred
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