Director of Quality Control and Assurance

3 days ago


Philadelphia, Pennsylvania, United States Adaptimmune Full time
Job Title: Director of Quality Control and Assurance

Adaptimmune is a leading cell therapy company with a strong commitment to quality and excellence. We are seeking a highly experienced and skilled Director of Quality Control and Assurance to join our team.

Job Summary:

The Director of Quality Control and Assurance will be responsible for leading the Quality Control and Assurance team to ensure the highest quality standards are met in the manufacture of our cell therapy products. This includes ensuring compliance with regulatory requirements, developing and implementing quality systems, and providing leadership and guidance to the team.

Key Responsibilities:
  • Lead the Quality Control and Assurance team to ensure the highest quality standards are met in the manufacture of our cell therapy products.
  • Develop and implement quality systems to ensure compliance with regulatory requirements.
  • Provide leadership and guidance to the team to ensure effective communication and collaboration.
  • Ensure robust laboratory investigations are performed to identify root cause for Out of Specification or unexpected results.
  • Develop and manage the operating budget for the department.
  • Support strategy development for content provided to regulatory agencies.
Qualifications and Experience:

We are seeking a highly experienced and skilled individual with a strong background in quality control and assurance. The ideal candidate will have:

  • A Bachelor's degree in a relevant science discipline, such as chemistry or microbiology.
  • At least 12 years of relevant work experience, including 5 years of leadership experience with direct reports.
  • Strong knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products.
  • Expertise in requirements for analytical methods, method transfer, qualification and validation for compendial and product specific analytical methods, stability, and QC release testing for advanced therapy.
What We Offer:

Adaptimmune offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to creating a diverse and inclusive work environment and welcome applications from all qualified candidates.



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