Manager/Sr. Manager, Quality Assurance Validation

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.

The Manger / Sr. Manager, Quality Assurance Validation is responsible for leading Validation activities and providing technical oversight, ensuring compliance of Change Control, Maintenance and Calibration activities with internal company Quality Systems, FDA and other regulatory requirements.

Location : Morrisville, NC - Onsite

Education and Experience

• BS degree in Engineering or Science and / or equivalent combination of education and experience required.
• 8+ years of work experience in a current Good Manufacturing Practices (cGMP) environment with progressive validation related responsibilities.
• Experience developing and executing validation strategies for multiple phases of clinical and commercial development required in either biotechnology, pharmaceutical, or medical device industries.
• Experience with new product introduction is preferred.
• Experience in the areas of Validation (Risk Assessment, Gap Assessment, IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.

and Process Excellence Methodologies (Six-Sigma, Lean, etc.)

Knowledge, Skills, and Abilities

• Excellent written and verbal communication and technical writing skills.
• Strong organizational skills with an ability to prioritize and enable and accelerate multiple programs and projects.
• Able to communicate, influence, inspire, learn and teach horizontally and vertically within a multi-disciplined organization.
• Strong desire to work as part of multiple cross-functional teams consisting of technical, scientific and non-technical team members.
• History of enabling team success.
• Continuously evaluate and evolve Liquidia’s Validation Policy and Procedural level documents to ensure compliance with current regulatory (FDA, etc.) expectations.
• Create, revise, review and approve documentation in Quality Assurance systems including SOPs, validation plans and protocols, risk assessments, validation deviation investigations, and change controls.
• Serve as internal expert on validation in support of partner and regulatory audits.
• Support / lead technical investigations.
• Review and approve PM, calibration, and non-routine maintenance work orders.
• Perform internal systems and compliance audits.
• Partner closely and seamlessly across all departments to enable the entire team’s mutual growth, development and overall success.
• Other duties, as assigned.

Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!

Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

Recruiting Agencies, Please Note :

Liquidia will not accept unsolicited assistance from recruiting / search agencies for this employment opportunity. Please, no phone calls or emails.

All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and / or method without a valid written search / recruitment agreement in place for this position will be deemed the sole property of Liquidia.

No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.