Senior Director, Global Quality & Regulatory - Exton, PA

Senior Director, Global Quality & Regulatory

Location:

Exton, PA/USA

We’re building our Biomedical Quality leadership team in Exton, PA—hiring for Senior Director, Global Quality & Regulatory. This critical role provides enterprise leadership for the quality and regulatory agenda, ensuring compliance with applicable regulatory requirements, maintaining product integrity and customer confidence, and enabling sustainable business growth through strong quality systems, governance, and performance.

As a member of the Global Leadership Team, you will serve as the global head of Quality & Regulatory for Biomedical, accountable for setting strategy, driving execution, and fostering a culture of compliance, continuous improvement, and operational excellence across all sites and functions. The role requires advanced knowledge of cGMP, ISO standards, ASTM standards, design controls, risk management, change control, and regulatory requirements.

• Define and lead the global Quality & Regulatory strategy for Biomedical, aligned with business priorities, innovation objectives, and geographic expansion; oversee the development, documentation, and implementation of quality procedures and standards across the organization.
• Ensure the effectiveness, compliance, and continuous improvement of the global quality management system, and compliance with applicable U.S. and international regulatory requirements governing medical devices, biomaterials, and related products.
• Serve as the senior quality and regulatory interface with customers, notified bodies, and regulatory agencies on matters related to compliance, audits, and product standing; ensure effective supplier engagement and oversight, including performance of required supplier audits.
• Build, lead, and develop a high‑performing global Quality & Regulatory organization, including talent development, succession planning, and organizational capability building.
• Serve as a key member of the Biomedical leadership team, contributing to enterprise risk management, strategic decision‑making, and business performance.

• Minimum of 15 years of experience in Quality Assurance and/or Regulatory Affairs, preferably within medical device manufacturing, biomaterials, or another regulated life sciences environment.
• Minimum of 10 years of progressive leadership experience in quality systems and processes within a regulated and internationally operating environment.
• Deep knowledge of quality management systems and regulatory frameworks applicable to medical devices and related products for a Class III medical device operation (21
  
  CFR 820, ISO 9001, 13485, 14001, 45000); experience with clean room theory and operation is a plus.
• Demonstrated experience in change management, team leadership, and organizational development; global quality experience and experience in the pharmaceutical industry a plus.
• Experience and success with Lean Manufacturing implementation and working knowledge of tools such as 5S, Kanban, Kaizen events, visualization, and standardized work.
• Bachelor’s degree required, preference for a degree in Engineering or a related technical discipline. Auditing certification is preferred.

Salary range: $157,200 - $225,000 per annum.

• A culture that prioritizes safety and well‑being, both physically and mentally.
• A firm belief that working together with our customers is the key to achieving great things.
• A space to grow by encouraging and supporting curiosity and an open mindset.
• The opportunity to work for a company where sustainability is core to its strategy and purpose.
• Barrier‑free communities within the organization where every employee is equally valued and respected, regardless of background, beliefs, or identity.
• An eagerness to be one team and learn from each other to bring progress to life and create a better future.

We’re proud to be an equal opportunity employer and are committed to fair, inclusive hiring practices. We welcome candidates from all backgrounds and provide support for applicants with disabilities. If you require assistance during the application process, let us know and we will accommodate you.