Director of Quality Assurance

4 days ago

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

Adaptimmune is a leading biotechnology company dedicated to developing innovative cell therapies for cancer treatment. We are seeking a highly skilled Director, Quality Assurance, to join our team and play a key role in ensuring the quality and integrity of our products.

Job Summary

The Director, Quality Assurance, will be responsible for leading our Quality Assurance department and providing quality oversight for our clinical trials, external manufacturing, quality systems, research and development, and regulatory activities. This role will require strong leadership and communication skills, as well as a deep understanding of quality systems, regulatory requirements, and industry best practices.

Key Responsibilities
  • Lead the Quality Assurance department and provide quality oversight for clinical trials, external manufacturing, quality systems, research and development, and regulatory activities.
  • Develop, implement, and maintain quality systems and processes to ensure compliance with regulatory requirements and industry best practices.
  • Collaborate with cross-functional teams, including Clinical Operations, Medical Affairs, Regulatory, and Contract Research Organizations, to ensure quality and compliance.
  • Develop and implement training programs to ensure quality awareness and compliance among employees.
  • Conduct audits and inspections to ensure compliance with quality systems and regulatory requirements.
  • Develop and implement corrective action plans to address quality issues and deviations.
  • Provide quality oversight for external manufacturing and testing, including site qualification, collection, labeling, and product manufacturing and batch release.
  • Manage partnerships with drug product manufacturers to ensure compliance with regulatory requirements.
  • Develop and implement global change management programs to ensure quality and compliance.
Qualifications and Experience
  • Bachelor's or Master's degree in Pharmaceutical Sciences, Physical Sciences, or related Life Sciences.
  • Minimum of 5 years of experience in the pharmaceutical, biologics, or biotech industry with demonstrated knowledge of quality systems, regulatory requirements, and industry best practices.
  • Strong leadership and communication skills, with the ability to lead cross-functional teams and collaborate with stakeholders.
  • Deep understanding of quality systems, regulatory requirements, and industry best practices.
  • Ability to develop and implement quality systems and processes to ensure compliance with regulatory requirements and industry best practices.
  • Experience with auditing and inspections, including site qualification, collection, labeling, and product manufacturing and batch release.
  • Ability to develop and implement corrective action plans to address quality issues and deviations.
Desirable Qualifications
  • Previous experience working in Quality Assurance within the cell and gene therapy industry.
  • Experience working with human T-cells, primary human cells, or similar biological systems.
  • Ability to lead a group of Quality Assurance specialists.
  • Previous experience working collaboratively with Contract Manufacturing Organizations and Qualified Persons in the EU.

Adaptimmune is an equal opportunities employer and welcomes applications from all qualified candidates. We are committed to diversity and inclusion in the workplace and believe that a diverse and inclusive team is essential to our success.

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