Director of QA - Cell & Gene Therapy

Posted 27 April 2023
Salary Competitive
LocationUnited States of America
Job type Full Time
Discipline Small Molecule
Contact NameJarel Jack

Job description

Mantell Associates is partnered with a leading Cell & Gene Therapy biotech, and they are seeking an experienced Director of Quality Assurance to lead and manage the quality assurance function for their manufacturing and development operations. The Director of Quality Assurance will be responsible for ensuring compliance with regulatory requirements, developing and implementing quality systems and processes, and ensuring the highest standards of quality and safety are met.

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Responsibilities:

  • Develop and implement the company's quality assurance strategy to ensure compliance with regulatory requirements and industry standards

  • Lead and manage the quality assurance team, providing guidance and support to ensure the team meets performance objectives

  • Develop and implement quality systems and processes to ensure the highest standards of quality and safety are met

  • Monitor and ensure compliance with GxP regulations, including GMP, GLP, and GCP

  • Oversee the qualification and validation of manufacturing processes, including equipment, facilities, and utilities

  • Lead the internal and external audit programs, ensuring compliance with regulatory requirements and industry standards

  • Manage the documentation system to ensure accuracy, completeness, and compliance with regulatory requirements

  • Ensure appropriate training and development of the quality assurance team

Requirements:

  • Bachelor's or Master's degree in life sciences or related field

  • Minimum of 10 years of experience in quality assurance within the biotechnology or pharmaceutical industry, with a focus on cell and gene therapy

  • Strong knowledge of GxP regulations, including GMP, GLP, and GCP

  • Experience in leading and managing a team of quality assurance professionals

  • Proven track record in developing and implementing quality systems and processes

  • Experience in managing and conducting internal and external audits

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Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.