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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 in targeting and eradicating cancer cells across various solid tumors.

We foster a workplace culture built on 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 different phases, 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 optimal patient outcomes.
  • Collaborate with cross-departmental teams to advance global initiatives and quality goals.
  • Establish and sustain quality management systems to support both manufacturing and clinical operations.
  • Ensure adherence to regulatory standards and spearhead initiatives for ongoing 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.
  • Proven leadership abilities and adept problem-solving skills.

Preferred Qualifications

  • Experience in quality assurance related to cell and gene therapies.
  • Familiarity with human T-cells and biological systems.
  • Capability to lead and collaborate effectively with external stakeholders.

We are committed to promoting diversity and equal opportunity within our organization. We welcome applications from qualified candidates of all backgrounds.