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Head of Quality Assurance

2 months ago

Philadelphia, Pennsylvania, United States Adaptimmune Full time
Director, Quality Assurance

Adaptimmune is at the forefront of biopharmaceutical innovation, focusing on immunotherapy solutions for cancer treatment. Our cutting-edge technology is designed to enhance T-cell efficacy, aiming to target and eradicate cancer cells across various solid tumors.

We foster a workplace culture rooted in trust, collaboration, and transparency, dedicated to positively impacting the lives of individuals battling cancer.

Key Responsibilities

  • Oversee quality assurance for clinical studies, external production, quality management systems, research and development, and regulatory compliance.
  • Lead a team of quality assurance professionals to ensure the timely provision of patient therapies while promoting continuous enhancement.
  • Develop, refine, and uphold quality processes appropriate for each phase, adhering to Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards.
  • Manage partnerships with Contract Manufacturing Organizations (CMOs) and Qualified Persons (QPs) to ensure compliance and achieve successful patient outcomes.
  • Collaborate with cross-functional teams to support global quality initiatives and objectives.
  • Establish and maintain quality management systems to facilitate manufacturing and clinical operations.
  • Ensure adherence to regulatory standards and spearhead initiatives for continuous improvement.

Qualifications

Essential Requirements

  • Bachelor's or Master's degree in Pharmaceutical Sciences or a related discipline.
  • Experience within the pharmaceutical or biotechnology sector with a solid understanding of GCP compliance.
  • In-depth knowledge of clinical drug development, GMP, and regulatory frameworks.
  • Demonstrated leadership and problem-solving capabilities.

Preferred Qualifications

  • Experience in quality assurance for cell and gene therapies.
  • Familiarity with human T-cells and biological systems.
  • Proven ability to lead and collaborate effectively with external partners.

We are committed to promoting diversity and equal opportunity within our workforce. We encourage qualified candidates from all backgrounds to consider this opportunity.