VP Quality Assurance & Regulatory Affairs

The Vice President of Quality Assurance (QA) is responsible for Sterigenics' global quality systems and regulatory compliance.

This role drives the company's quality strategy, ensures compliance with international standards and regulatory agencies, and fosters a culture of continuous improvement.

The VP reports directly to the President and leads a global team, including seven direct reports and dotted-line oversight of Quality Managers across 48 facilities.

Key Responsibilities

Quality & Regulatory Leadership


* Ensure compliance with FDA, USDA, JPAL, ISO, and other global regulatory requirements.


* Serve as the company's Management Representative for ISO and primary FDA correspondent.


* Oversee the Quality Management System, Internal Audit Program, and executive-level management reviews.


* Lead initiatives for continuous improvement and maintain plant DMF and MAF filings with the FDA.


* Represent Sterigenics with national and international standards groups (AAMI, ASQC, ASTM).

Operational Excellence


* Partner with Operations, Sales, and Engineering to embed best practices, resolve customer issues, and support capital projects while ensuring regulatory compliance.


* Champion cross-functional collaboration to drive productivity and quality improvements.

Customer Focus


* Engage with customers to communicate Sterigenics' quality philosophy and address their needs.


* Develop and maintain service quality metrics and reporting systems to ensure consistent delivery and accountability.

Financial & Strategic Management


* Develop and manage the QA organization's budget, aligning with company financial goals.


* Contribute to fiscal objectives by integrating quality practices into operational performance.

People Leadership


* Recruit, develop, and retain top-quality assurance talent with potential for advancement.


* Enhance training programs to strengthen technical, leadership, and interpersonal skills.


* Contribute to performance evaluations of Quality Managers in partnership with site and operations leaders.

Qualifications


* Bachelor's degree in health sciences, engineering, or related technical discipline (advanced degree preferred).


* 15+ years of progressive leadership in quality assurance or engineering within the medical device or pharmaceutical industry.


* Expertise in global quality systems, FDA GMP compliance, process validation, and statistical quality tools.


* Proven success managing large, geographically diverse teams and complex global operations.

Leadership Attributes


* Collaborative, hands-on leader who inspires confidence and credibility at all levels.


* Strong communicator with the ability to influence and negotiate across functions and cultures.


* Integrity, professionalism, and a reputation for high ethical standards.


* Innovative problem-solver with the ability to simplify and execute complex ideas.


* Global mindset...