Senior Director, Global Quality & Regulatory - Exton, PA

dsm-firmenich • Exton, PA

10d • $157,200 - $225,000 • Onsite

About The Position

We’re building our Biomedical Quality leadership team in Exton, PA – we’re hiring for Senior Director, Global Quality & Regulatory. This is a critical role at Exton that 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.
This member of the Global Leadership Team serves as the global head of Quality & Regulatory for Biomedical and is accountable for setting strategy, driving execution, and fostering a culture of compliance, continuous improvement, and operational excellence across all sites and functions. Senior Director, Global Quality & Regulatory operates in a highly regulated environment requiring advanced knowledge of cGMP, ISO standards, ASTM standards, design controls, risk management, change control, and quality system and regulatory requirements.
Local drivers of success rely on your ability to operate in a highly regulated, global environment, where close collaboration with site leadership, operations, R&D, commercial teams, customers, suppliers, and external regulatory bodies occurs. The position is based on-site in Exton, PA and requires regular physical presence at the facility to lead cross-functional decision-making, quality governance, talent development, and site engagement.
We are a leading biomaterials partner to global medical device and pharmaceutical companies, with more than 30 years of expertise in biomaterial science, process innovation, regulatory support, and high-quality manufacturing. The business is recognized for its broad portfolio, proprietary processing capabilities, strong intellectual property, and extensive experience supporting customers worldwide.
At dsm-firmenich people are at the heart of the company. We are committed to equal employment opportunities and value diversity in the workplace.

Requirements

• 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 required
• 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 (21CFR 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, standardized work
• Bachelor’s degree required with preference for a degree in Engineering or a related technical discipline.

Nice To Haves

• experience with clean room theory and operation is a plus
• Auditing certification is preferred

Responsibilities

• 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.
• Ensure 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

Benefits

• 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 much more than a claim and is core to our strategy and purpose
• Barrier-free communities within our organization where every employee is equally valued and respected – regardless of their 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior