VP Quality Assurance & Regulatory Affairs

Overview

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.

• Quality & Regulatory Leadership:
  Ensure compliance with FDA, USDA, JPAL, ISO, and other global regulatory requirements.
• Quality Management:
  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.
• Quality Filings:
  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.
• Cross-functional Collaboration:
  
  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.

• 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.

• 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 and sensitivity to diverse cultures and work environments.

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.

Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of…