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.
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Seniority level
Executive -
Employment type
Full-time -
Job function
Quality Assurance -
Industries
Biotechnology Research
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