Your mission

Sr. Director, Quality Systems and Compliance

Pierre Fabre, the second-largest private French pharmaceutical group and the world's second-largest dermo-cosmetics lab offers you a dynamic, purpose-driven career.  

Primarily owned by The Pierre Fabre Foundation, a government-recognized public-interest foundation, we take pride in our expertise in oncology. 

Beyond being employees, we act as entrepreneurs, and our work is a pursuit of purpose and performance. Join us in our mission to protect and preserve the health and sustainability of all people and our planet. Innovate, collaborate with healthcare professionals, and make a difference with "New Ways to Care."  

Join Pierre Fabre Pharmaceuticals to make a real impact in people's lives. Your purposeful career begins here. 

SUMMARY: 

We are seeking an experienced, highly motivated, and well-organized Quality professional to join our fast-paced, growing Cell Therapy company.  This position is responsible for leading Quality Systems and Compliance for Pierre Fabre Pharmaceuticals US - Cell Therapy.  Ensuring the highest standards of quality and compliance across all aspects of our operations. Reporting directly Head of Quality, you will lead the development, implementation, and maintenance of quality systems and processes to meet regulatory requirements and industry best practices.

ESSENTIAL FUNCTIONS:

• Strategic Leadership: Develop and execute strategies to establish and maintain a robust quality management system (QMS) that aligns with global regulatory requirements and industry standards.
• Regulatory Compliance: Serve as a point of contact for regulatory agencies and ensure compliance with applicable regulations, including but not limited to FDA, EMA, and other international regulatory authorities.
• Quality Systems Development: Lead the design, implementation, and continuous improvement of quality systems, including document control, training, deviation management, change control, and CAPA processes.
• Document Control: Experience in developing and managing document control processes, including document creation, review, approval, distribution, and archival, to ensure compliance with regulatory requirements and internal quality standards. Familiarity with electronic document management systems is required.
• Deviation Management: Demonstrated expertise in implementing deviation management systems to investigate, document, and resolve deviations from established procedures and specifications. Ability to lead root cause analysis investigations and implement corrective and preventive actions (CAPAs) to prevent recurrence.
• Supplier Quality Management: Knowledge of supplier quality management processes, including supplier selection, qualification, and ongoing monitoring. Experience in conducting supplier audits and managing supplier corrective actions to ensure the quality and reliability of raw materials and components.
• Quality Metrics and Reporting: Proficiency in defining and monitoring key quality metrics to assess the performance of quality systems and identify opportunities for improvement. Ability to prepare comprehensive quality reports and presentations for management review and regulatory submissions.
• Audits and Inspections: Prepare the organization for regulatory inspections and internal/external audits, ensuring readiness and compliance with regulatory requirements. Lead responses to audit findings and observations.
• Risk Management: Implement risk-based approaches to identify, assess, and mitigate quality and compliance risks throughout the product lifecycle.
• Training and Development: Develop and deliver comprehensive training programs on quality systems, regulatory requirements, and compliance expectations to ensure staff competency and adherence to quality standards.
• Cross-Functional Collaboration: Collaborate closely with other departments, including Manufacturing, Research and Development, Clinical Operations, and Regulatory Affairs, to ensure quality and compliance considerations are integrated into business processes.
• Continuous Improvement: Drive a culture of continuous improvement by monitoring key quality metrics, analyzing trends, and implementing initiatives to enhance quality performance and efficiency.
• Quality Culture: Foster a culture of quality and compliance excellence throughout the organization by promoting awareness, accountability, and ownership of quality responsibilities at all levels.

REQUIRED EDUCATION AND EXPERIENCE:

• Bachelor’s degree in a scientific or engineering discipline; advanced degree preferred.
• Minimum of 15+ years of leadership experience in Quality Assurance/Quality Control leadership role