Demo

Vice President Regulatory Affairs Quality Assurance

Aquarius Professional Staffing
Cincinnati, OH Full Time
POSTED ON 2/9/2025
AVAILABLE BEFORE 5/8/2025

Vice President Regulatory Affairs Quality Assurance

Are you a driven VP of Global Quality Assurance and Regulatory Affairs looking to be a vital asset to a growing organization based here in the Cincinnati area? Don't miss your chance and apply now!

What you will get as the VP of Global Quality Assurance and Regulatory Affairs :

  • Collaborate with senior management and cross-functional project teams to develop and lead regulatory strategies.
  • Utilize domain and industry-specific knowledge to foster buy-in and participation across business lines and functions, ensuring effective governance, assurance, and improvement of the processes required to comply with the complex array of regulations that govern Company operations.
  • Incorporate a global regulatory strategy, regulatory filings, supply chain operations, marketing, sales and external partnerships.
  • Lead a global, multisite, cross-business function responsible for a world-class quality management system inclusive of product development, manufacturing, sourcing, distribution and value-added services.
  • Drive continuous improvement and adaptation of QARA processes to support customers in a growing and expanding business environment.
  • Build a culture of awareness, accountability and consistency across the company’s current and future business lines.
  • Work closely with other business and functional leaders in driving high quality global processes suited to the range of Company's business operations while maintaining a separation of duties and accountabilities between these functions.
  • Ensure that functional performance meets the guidelines for compliance with global regulations and standards ISO9001, EN ISO13485 and FDA / cGMP Quality Management System requirements.
  • Manage and lead the ISO 9001 / 13485 Internal Audit program.

What you will need as the VP of Global Quality Assurance and Regulatory Affairs :

  • Bachelor's Degree.
  • 6 years of Global Quality Assurance
  • Regulatory Affairs experience.

  • Proven success in a management role.
  • Must have Lean Six Sigma experience.
  • Strong understanding of regulatory requirements and relevant standards, including ISO Standards or regulatory agencies.
  • Experience in implementing Quality processes related to design controls and risk management.
  • Leadership and interpersonal skills to develop and manage good working relationships with internal departments.
  • Very strong risk / auditor skills – critical to evaluate remediation of issues and management’s action plans.
  • Ability to travel globally up to 25%.
  • Seniority level

    Director

    Employment type

    Full-time

    Job function

    Quality Assurance and Management

    Industries

    Manufacturing

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