Qnovia, Inc Director of Quality Remote · Full time

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.

Description

Qnovia, Inc. and its People

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.

 

Position Overview

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

 

Essential Functions and Responsibilities

  • Establish appropriate programs, policies, and procedures to put in place and maintain appropriate QMS compliance for the company’s development efforts in line with FDA requirements.
  • Define quality standards, prepare work inspections or test procedures, and determine examination points.
  • Lead the development and administration of the corrective and preventative actions, internal non-conformance, Quality Management Systems, and ISO compliance.
  • Develop, manage, monitor, and report Operational and Quality Key Performance Indicators (KPI).
  • Provide technical expertise in product development projects, design reviews, order entry, bills of material verification, validation and manufacturability involving R&D, Product Group, Procurement, Manufacturing, Technology of Transfer, and other responsibilities.
  • Develop, review, maintain, manage, continually improve, and approve of QMS processes.
  • Present improvement projects and activities to management.
  • Compile and write training material and conduct training sessions on improvement tools and methodologies or other key business projects.
  • Ensure applicability of current quality policies, procedures, and objectives by keeping informed of the latest updates/modifications related to ISO quality systems.
  • Review and evaluate in-process rejections, obtain disposition, and implement containment, corrective, and preventative action.
  • Schedule and perform audit activities, to include pre-audit planning, audit execution and evaluation and post-audit follow-up and recommendations.

 

Position Requirements

  • BS Degree in Engineering, Computer Science, or other technical or scientific field; equivalent years of experience in lieu of degree may be considered
  • Previous experience in a Pharmaceutical manufacturing environment
  • Background in developing, implementing, and managing quality systems
  • At least six (6) years’ experience in developing procedures, identifying key process control points, technical writing, auditing, statistical reporting, database development, and defining inspection and testing criteria
  • Fluency in protocols, work practices and procedures required to successfully support the quality assurances of the product
  • Technical aptitude and ability to read and understand technical documents and drawings
  • Analysis and decision-making skills to solve complex problems
  • Ability to work in a fast-paced environment, simultaneously manage several objectives and reassign priorities
  • Strong communication skills and ability to work with a diverse team and individually
  • Ability to work effectively under minimal supervision
  • Strong leadership and project management skills
  • Physical and mental capabilities to accomplish the essential functions of the position with or without a reasonable accommodation

 

Salary

$120,000 - $150,000 per year