Job Description

Rx Group is recruiting an Executive Director of Quality Assurance for a clinical stage cell therapy biotech in California. Reporting directly to the Senior Vice President of Quality, the Executive Director of Quality will play a pivotal role in ensuring compliance with regulatory requirements, driving continuous improvement initiatives, and maintaining a culture of quality excellence throughout the organization.

Key Responsibilities:

• Develop and implement the overall quality strategy in alignment with company goals and regulatory requirements.
• Provide strategic direction and leadership to the quality assurance and control teams.
• Ensure compliance with relevant regulations and guidelines, including FDA, EMA, and other international regulatory authorities.
• Oversee the preparation for regulatory inspections and support regulatory submissions as needed.
• Establish and maintain robust quality systems to support late-phase clinical development activities.
• Monitor and evaluate the effectiveness of quality systems and processes, implementing improvements as necessary.
• Develop and maintain quality assurance programs to ensure product safety, efficacy, and compliance with specifications.
• Conduct internal audits and oversee vendor audits to assess compliance with quality standards.
• Identify and assess quality risks associated with cell therapy manufacturing and clinical development activities.
• Develop risk mitigation strategies and ensure their effective implementation.
• Recruit, mentor, and develop a high-performing quality team capable of supporting the company's growth and objectives.
• Provide coaching and guidance to team members to foster a culture of continuous learning and improvement.

Qualifications:

• Bachelor's degree in a relevant scientific discipline; advanced degree preferred.
• Minimum of 10 years of experience in quality assurance and control within the biopharmaceutical industry, with specific experience in cell therapy highly desirable.
• In-depth knowledge of FDA and international regulatory requirements for late-phase clinical development.
• Proven track record of leading successful quality initiatives and driving continuous improvement.
• Strong leadership and communication skills, with the ability to collaborate effectively across functions and levels of the organization.

This is a full-time, hybrid position based in California. The Executive Director of Quality will have the opportunity to make a meaningful impact on the development and commercialization of innovative cell therapies while working in a dynamic and collaborative environment. If you are passionate about quality and driven to make a difference in patients' lives, we encourage you to apply directly or reach out to Hemish Ilangaratne at h.ilangaratne@rx-group.io.