Quality Assurance Leader with Expertise in Regulatory Compliance

6 days ago

Louisville, Kentucky, United States Eurofins GSC Poland Sp. z o. o. Full time

At Eurofins Genomics, we are seeking an experienced Director of Quality and Regulatory Affairs to lead our Quality department. The ideal candidate will champion quality and compliance initiatives, develop and implement process improvements, and ensure adherence to regulatory standards.

About the Role
  • 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 customers and ensure high levels of satisfaction.

Salary: $120,000 - $180,000 per year. Benefits include comprehensive medical coverage, dental, and vision options, life and disability insurance, 401(k) with company match, paid vacation and holidays.

Eurofins 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 products, cutting-edge technology, and exceptional turn-around-times to support customers in a wide variety of genomics applications.

The ideal candidate will 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.
    • Familiarity with air pollution control reporting, waste registration, and regulatory compliance.
  • Leadership Abilities: Proven experience in building and managing effective teams.
  • Communication Skills: Excellent verbal and written communication skills for interfacing with internal teams, regulatory bodies, and customers.
  • Problem-Solving Skills: Strong analytical and decision-making abilities with a proactive mindset.
  • Hands-On Approach: Willingness to engage directly with processes and teams to drive improvements.

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