Associate Director Quality Assurance

🚀 Associate Director, Quality Management

🏭 Manufacturing | Quality Leadership

A regulated, global manufacturing organization is seeking an Associate Director, Quality Management to lead site-wide quality strategy and drive cultural transformation at a large, complex operation.

This is a senior leadership role with high visibility, influence, and long-term growth potential for a quality leader who thrives in change-oriented environments.

• Serve as the site Quality Leader overseeing Quality Assurance, Quality Control, Quality Systems & Compliance, and Quality Engineering
• Act as the management representative for regulatory bodies, notified bodies, and customers
• Lead GMP-compliant quality systems, including CAPA, audits, validation, change control, document control, and complaint management
• Drive quality transformation and continuous improvement in partnership with Manufacturing, Engineering, and Supply Chain
• Build, coach, and develop a high-performing quality organization
• Champion a culture of quality excellence, accountability, and urgency
• Play a key role on the site leadership team while aligning with global quality strategy

• Bachelor’s degree in a technical or scientific field (advanced degree preferred)
• 10+ years in highly regulated manufacturing environments
• 10+ years of plant-level Quality leadership experience
• Strong working knowledge of 21 CFR 820, 210/211, ISO 9001, and ISO 13485
• Proven ability to lead change and elevate quality culture
• Experience interfacing with customers and regulatory agencies
• Continuous Improvement mindset with the ability to influence at all levels

• Critical leadership position at a flagship manufacturing site
• Opportunity to drive real, structural change rather than maintain the status quo
• Clear runway for future advancement within a global organization
• Competitive compensation, including LTI, benefits, and relocation support for the right candidate

Visa candidates are not being considered for this role