The Director of Quality leads the Quality function for Qnovia, Inc. and is responsible the company’s Quality Compliance infrastructure, including the oversight of all partner manufacturing facilities in collaboration with other site Quality Managers. To meet company, FDA, and customer quality expectations, the incumbent identifies opportunities, develops and plans improvements, executes and supports improvements, and ensures results are achieved and sustained, utilizing statistical thinking and methodologies. Serves as the in-house advisor to all departments to facilitate and lead quality improvement activities. Coordinates and executes plans to maintain compliance with FDA requirements for Medical Devices and Pharmaceutical Drug Product, including ISO 13485.
Qnovia, Inc. is a venture-backed pharma-development company whose goal is to improve patient outcomes. The company has developed an innovative inhaled drug delivery technology with broad application across indication areas. The companies first application to the FDA seeks approval as a prescription inhaled smoking cessation therapy. In addition to smoking cessation the company is focused on applications for asthma, COPD, pain management, migraine relief and more.
Qnovia has raised $30MM to date and recently closed a $17MM A round to fund the smoking cessation program. Candidates can work remote but will be required to travel as needed. As a start-up, we operate in a fast-paced environment. Candidates must be able to operate with autonomy, be nimble and creative in problem solving. Candidates must be proficient in leading outside vendors and must be able to be collaborative with both internal and external stakeholders.
Experience in pharmaceutical drug development and FDA-regulated businesses, along with proven success in entrepreneurial environments, are preferred.
Salary and equity opportunities are commensurate with candidate qualifications and experience.
Job Title: Director of Quality
Reports To: CEO
FLSA Status: Exempt
Work Location: Remote (Home Office or Co-Working Space)
Travel: As needed for internal company activities and to partner sites
$120,000 - $150,000 per year