Senior Director of Quality Control

10 hours ago


Holly Springs NC USA, United States FUJIFILM Corporation Full time
About the Role

FUJIFILM Diosynth Biotechnologies is seeking a highly skilled and experienced Senior Director of Quality Control to join our team in Holly Springs, North Carolina. As a key member of our site leadership team, you will be responsible for developing and implementing the quality control strategy for our new facility, ensuring compliance with regulatory requirements and industry best practices.

Key Responsibilities
  • Develop and implement the quality control strategy for the Holly Springs site, aligning with the global quality strategy.
  • Build, develop, and lead the quality control team, providing clear priorities, feedback, and career development opportunities.
  • Create and transition the quality control department to a new state-of-the-art laboratory.
  • Lead the growth and expansion of the quality control team at the site, including regional accountabilities for intra-company testing.
  • Provide strategic decision-making, prioritizing deliverables to meet site and compliance objectives.
  • Oversee all quality control operations, including in-process testing, bulk release, and stability testing, microbiological testing, environmental and utility monitoring.
  • Support and participate in client visits, audits, and regulatory agency inspections.
  • Ensure budgets, timelines, schedules, and performance requirements are established and met.
  • Assure all areas of responsibility conform to cGMP and other appropriate regulatory requirements.
Requirements
  • Bachelor's Degree in Chemistry, Biochemistry, Microbiology, or related field with 15+ years of experience, or Master of Science (M.Sc.) in a related discipline with 13+ years of experience, or PhD in Science with 10+ years of experience.
  • At least 7 years of leadership/management experience.
  • Technical and regulatory understanding and experience of biologics, gene, and/or cell therapy QC with an understanding of control strategy.
  • Experience leading client site visits, audits, and regulatory inspections.
About FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies is a leading contract development and manufacturing organization (CDMO) that provides a comprehensive range of services to support the development and manufacture of biologics, vaccines, and gene therapies. Our team of experts is dedicated to delivering high-quality products and services that meet the needs of our clients.



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