Job Description
Eurofins Genomics is a global leader in providing high-quality genomics services and solutions for academic, clinical, and industrial customers. As a trusted partner, Eurofins combines high quality product, cutting-edge technology, and exceptional turn-around-times to support customers in wide variety of genomics applications. Join our mission-driven team at our ISO 13485 certified facility and contribute to advancing life sciences through excellence and innovation.
We are seeking an experienced and dynamic Director of Quality and Regulatory Affairs to lead and strengthen our Quality department. The ideal candidate will champion quality and compliance initiatives, develop and implement process improvements, and ensure adherence to regulatory standards. This role requires a hands-on leader passionate about driving operational excellence in a fast-paced, highly collaborative environment.
Responsibilities
As the Director of Quality and Regulatory Affairs, you will:
Lead Quality Management Systems (QMS): Maintain and enhance the ISO 13485/ ISO 9001 certified QMS to ensure compliance with applicable standards and regulations, including FDA 21 CFR 820.
Lead Continuous Improvement Initiatives: Apply Lean Six Sigma principles and statistical process control methodologies to streamline operations, improve product quality, and reduce variability.
Root Cause Analysis: Investigate non-conformances and implement corrective and preventive actions (CAPAs) to address quality issues and prevent recurrence.
Regulatory Compliance: Oversee air pollution control reporting, hazardous waste registration, and related environmental compliance programs.
Quality Metrics: Develop and monitor key performance indicators (KPIs) to evaluate and improve the effectiveness of quality processes.
Team Leadership: Build, mentor, and manage a high-performing Quality team, fostering a culture of accountability, continuous improvement, and collaboration.
Internal and External Audits: Plan, conduct, and facilitate successful audits, addressing findings promptly and effectively.
Cross-Functional Collaboration: Work closely with process development, production, and other departments to align quality objectives with overall company goals.
Trainings: Manage safety / regulatory trainings for all employees and ensure compliance
Customer Feedback: Lead all quality related discussions with key customer and ensure high levels of satisfaction
