DSM

1 month ago

Senior Director, Global Quality & Regulatory

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Last checked: 10 hours agoStatus: Live

Job Summary

Senior leader responsible for defining and driving the global Quality & Regulatory strategy for Biomedical, ensuring compliance with cGMP, ISO and design controls, overseeing quality systems, regulatory affairs, supplier audits, and cross-functional governance to enable sustainable growth.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Sr. Director level

Key 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

Pay and Benefits

Salary: USD 157,200 - 225,000 annually

Key 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
•Minimum of 10 years of progressive leadership experience in quality systems and processes within a regulated, internationally operating environment
•Deep knowledge of quality management systems and regulatory frameworks applicable to medical devices (e.g., 21 CFR 820, ISO 9001, 13485, 14001, 45000) with exposure to clean room theory is a plus
•Proven experience with change management, team leadership, and organizational development; global quality experience and pharmaceutical industry experience considered a plus
•Bachelor’s degree required with preference for Engineering or related technical discipline; auditing certification is preferred

Experience:15+ yearsMedical devicesBiomaterialsLife sciencesQARegulatory AffairsQuality management systems

Education:Bachelor's

Skills:LeadershipCollaborationCommunicationStrategic thinkingRegulatory affairs

Certifications:Auditing

Languages:English

Company Brief

DSM

DSM-Firmenich is a global leader in food ingredients, nutrition, fragrances and beauty solutions, formed by the merger of DSM and Firmenich to provide sustainable, science-driven products and services across food, health and personal care industries.

Industry: Chemical Manufacturing

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Established Company

Headquarters: Geneva, Switzerland

Founded: 2023

Website LinkedIn

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DSM