Founder at Rx Group 🧬 Helping biotech’s bring safer medicines to patients, by finding them the best quality assurance talent. 🌎
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.
Seniority level
Executive
Employment type
Full-time
Job function
Quality Assurance
Industries
Biotechnology Research
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