Director of Quality Assurance

7 days ago


Memphis, Tennessee, United States DSJ Global Full time
Sr Director, QA

DSJ Global is seeking a highly experienced Sr Director, QA to lead our Quality Assurance team and ensure the highest standards of quality across multiple international sites.

Key Responsibilities:
  • Lead and Manage a Global Team: Oversee a team of Quality Assurance professionals to ensure consistent adherence to cGMP standards and regulatory requirements.
  • Develop and Implement Quality Strategies: Create and execute global quality strategies and initiatives that align with corporate objectives and regulatory expectations.
  • Oversee Quality Management Systems: Integrate and harmonize Quality Management Systems across all sites, promoting efficiency and standardization.
  • Support CDMO Operations: Provide oversight and support for all aspects of CDMO operations related to Biologics and CAR-T product manufacturing.
  • Collaborate with Cross-Functional Teams: Work closely with Manufacturing, Regulatory Affairs, and R&D teams to drive continuous improvement in quality processes and systems.
  • Ensure Regulatory Compliance: Serve as the primary point of contact for FDA and EMA inspections and audits, ensuring readiness and compliance at all times.
  • Monitor Quality Metrics: Analyze quality metrics and KPIs to identify trends, implement corrective actions, and drive a culture of quality excellence.
Qualifications:
  • Education: Bachelor's degree in a scientific or engineering discipline; advanced degree (Master's, PhD) preferred.
  • Experience: Minimum of 15 years of progressive experience in Quality Assurance within the biopharmaceutical industry, with at least 5 years in a leadership role overseeing global operations.
  • Knowledge and Skills: Extensive knowledge and experience with Biologics and/or CAR-T product manufacturing processes and regulatory requirements.
  • Leadership and Communication: Strong leadership and communication skills with the ability to influence and collaborate across diverse teams and cultures.
  • Travel: Ability to travel internationally as needed (approximately 30-40% travel expected).


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