Vice President of Quality

Rx Group is working with a clinical stage cell therapy biotech in the US, on the cutting edge of commercialising a new cell therapy for the treatment of cancer. The organisation is recruiting for an experienced Vice President of Quality to lead the QA/QC function and ensure the highest standards of quality and compliance across groundbreaking programs. Reporting directly to the CEO, the VP of QA will play a critical role in driving quality initiatives, overseeing clinical GCP aspects, and contributing to regulatory milestones.

Key Responsibilities:

• Develop and implement comprehensive quality assurance strategies and systems to support cell therapy programs.
• Lead and mentor a dedicated team of QA and QC professionals, fostering a culture of excellence and continuous improvement.
• Oversee clinical GCP activities, ensuring compliance with regulatory requirements and industry standards.
• Guide the organization through the BLA submission process, ensuring all quality documentation and data meet FDA and other regulatory body expectations.
• Collaborate closely with cross-functional teams, including Clinical, Regulatory, and Manufacturing, to ensure seamless integration of quality practices.
• Manage external relationships with contract manufacturing organizations (CMOs) and other key partners.
• Stay current with industry trends, regulatory changes, and best practices to continuously enhance quality systems.

Qualifications:

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Minimum of 10 years of experience in quality assurance within the biotech or pharmaceutical industry, cell therapy experience essential.
• Proven track record in leading QA teams and managing quality systems in a clinical and manufacturing environment.
• In-depth knowledge of GCP, GMP, and other relevant regulatory requirements.
• Experience with BLA submissions and navigating complex regulatory landscapes.
• Strong leadership , communication, and interpersonal skills.
• Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively.

If you are interested in this opportunity, please apply directly or contact Hemish Ilangaratne at h.ilangaratne@rx-group.io for more information.