Director of Quality Assurance

6 days ago

Raleigh, North Carolina, United States Cellectis Full time
Job Title: Director, Quality Control

Cellectis is a clinical-stage biopharmaceutical company dedicated to developing innovative cancer immunotherapies. We are seeking a highly skilled Director, Quality Control to join our team in Raleigh, NC.

Job Summary:

The Director, Quality Control will be responsible for overseeing all quality control functions at the Cellectis Raleigh facility, ensuring that our products meet the highest quality standards and regulatory requirements. This role will lead the Quality Control group, manage the quality control program, and establish and maintain quality control processes, policies, and standard operating procedures.

Key Responsibilities:
  • Lead and oversee the Quality Control group, ensuring the organization and administration of all quality control functions.
  • Develop and implement quality control processes, policies, and standard operating procedures to ensure compliance with regulatory requirements.
  • Manage the quality control program, including internal and external analytical testing of raw materials and products.
  • Collaborate with cross-functional teams, including Manufacturing, Quality Assurance, Analytical Development, and MSAT, to achieve company objectives.
  • Develop and coordinate the Quality Control laboratory activities and capabilities to provide timely, accurate, and cGMP compliant testing of raw materials, starting materials, in-process materials, and final product.
  • Ensure the proper investigation into the root cause of OOS/OOT results and assist in determining appropriate product disposition and/or method improvements.
  • Ensure that any internal and external laboratories comply with GMP standards.
Requirements:
  • Bachelor's Degree in Chemistry, Biology, or related sciences.
  • Minimum 12 years of experience in pharmaceutical testing laboratory.
  • 8+ years of direct supervisory experience.
  • Understanding and experience with relevant analytical and microbiological testing, methods development/validation, and environmental monitoring programs required to meet all regulatory requirements.
Preferred Qualifications:
  • Comprehensive knowledge of biological and microbial analysis, manufacturing operations, GMP's, and the theories and general principles behind them.
  • Understanding of laboratory equipment such as qPCR, Flow Cytometer, UV/Vis Spectrophotometer, Densitometer, Gel Imager, pH, Osmometer, etc.
  • Strong project management skills.
  • Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes team work, collaboration, influencing, motivating, and consensus and team building.

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