Director of Quality and Continuous Improvement

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

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

Qualifications

To excel in this role, you should possess:

• Education: Bachelor's or higher degree in Engineering, Life Sciences, or a related field.
• Experience: Minimum of 10 years in Quality Management within a regulated industry, with at least 5 years in a leadership role.
• Certifications: Lean Six Sigma certification strongly preferred.
• Technical Skills:
  • Expertise in statistical process control (SPC) and root cause analysis.
  • In-depth knowledge of ISO 13485, FDA 21 CFR 820, and quality systems regulations.
  • Familia