Director - Quality Management Systems

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Location: Irvine, CA US
Job Category: Quality & Regulatory Affairs
Position Description
Director - Quality Management Systems

As we strive for continuous improvement and future growth, we are looking for an experienced, passionate, and dynamic Director of Quality & Management Systems to support continuous improvements in Quality and Regulatory processes that are compliant to Global Medical Device standards and requirements to achieve Vyaire business goals.

Together we are building the world leader in Respiratory Care and desire to attract and retain people who routinely distinguish themselves by their own performance, bring innovation, & push the status quo. Join us as we improve patient outcomes, advance the quality of care, and improve value for our customers.

In particular you can expect to:

  • Develop quality plans, continuous improvement and leading Key Process Indicators and metrics for the global business.
  • Develop, implement, and maintain global and corporate GMP quality systems to support commercial and development activities for Vyaire products with sales in multiple countries and manufacturing locations.
  • Ensure in-process and finished products and processes conform to in-house policies and procedures as well as other applicable regulations and guidelines.
  • Coordinate and perform or assist in, as needed, all compliance audits and internal audit programs.
  • Standardize and streamline the CAPA, training, and Doc Control systems across all sites per applicable regulations.
  • Ensure that cGMP requirements and quality standards are recognized, understood and maintained through regular quality system management reviews.
  • Ensure in-process and finished products and processes conform to in-house policies and procedures as well as other applicable regulations and guidelines.
  • Budgetary and managerial responsibility for quality systems, multiple manufacturing sites, and doc control.
  • Work across all disciplines (e.g. manufacturing, operations, R&D, etc.) to ensure that the company sites maintain a state of readiness for inspection by regulatory agencies.
  • Keep current on quality regulations and guidelines, advice management team of any business implications of these changes.
  • Lead, manage, and ensure proper training to any relevant change management programs throughout the company.
  • Lead quality efforts in corporate development of analytical methods and provide quality guidance to product development projects and programs.
  • Represent QA at senior management, project, board, and review meetings.

You will have the opportunity to:

  • Improve patient outcomes
  • Meaningfully impact the company‚Äôs short-term and long-term success
  • Work closely with executives across the organization
  • Grow your role as you see fit
  • Learn everything there is to know about respiratory medical device manufacturing
  • Create an inspiring workplace

To be successful, you will need:

  • Quality professional with 15+ years of hands on experience with increasing responsibility in a QA function.
  • Prior responsibility for quality systems with an ability to critically evaluate and troubleshoot complex problems is essential.
  • Significant hands on experience in a class II/III medical device or biopharmaceutical company, including clinical and commercial products.
  • Hands on experience implementing quality systems in a GMP environment, and direct experience with FDA and other health authority inspections.
  • Extensive knowledge of US GXP compliance regulations and industry practices, as well as EU & International standards and country specific requirements.
  • Strong hands on leadership and management skills with an ability to effectively participate on multi-disciplinary teams.
  • Ability to absorb and relate detailed scientific, quality, and regulatory information.
  • Well-organized and detailed oriented professional, with strong verbal and written communication skills.
  • Need to be ready to live and embrace the Vyaire vision and culture of the company.

Education:

  • Degree (advanced degree preferred) in Quality Management or Engineering or relevant scientific discipline.

Some logistics:

  • Travel up to 30%
  • Location: Irvine, CA or Mettawa, IL

Irvine, CA, Mettawa- HQ

Full time
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