Overview
Vice President Regulatory Affairs Quality Assurance Jobs in Cincinnati, Ohio, USA at Aquarius Professional Staffing
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 ISO
9001, EN ISO
13485 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
AND 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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Title: Vice President Regulatory Affairs Quality Assurance
Company: Aquarius Professional Staffing
Location: Cincinnati, Ohio, USA
Category: Quality Assurance – QA/QC, Management
