We are currently seeking a highly skilled and experienced Director/Senior Director of Quality Control for Cell Therapy to join our client's growing team. In this role, you will be responsible for overseeing all quality control activities related to cell therapy Quality Control processes.

Key Responsibilities:

• Develop and implement quality control strategies and programs to ensure compliance with relevant regulations and industry standards.
• Manage a team of QC professionals, providing guidance and support in their daily activities.
• Oversee the testing and release of raw materials, intermediates, and final cell therapy products.
• Ensure timely and accurate completion of QC testing and documentation, including assay development, qualification, and validation.
• Collaborate with cross-functional teams to establish and maintain robust quality systems and processes.
• Participate in the development and review of protocols, SOPs, and other relevant documents.
• Identify and implement process improvements to enhance efficiency and effectiveness of QC operations.
• Ensure compliance with cGMP, FDA, and other applicable regulations and guidelines.
• Conduct investigations and root cause analyses for deviations, out-of-specification results, and non-conformances, and implement appropriate corrective and preventive actions.
• Provide technical expertise and leadership in troubleshooting and resolving QC-related issues.
• Develop and maintain strong relationships with internal and external stakeholders, including regulatory agencies and contract testing laboratories.

Requirements

Requirements:

• Achieved a PhD in a relevant scientific field with over a decade of experience in Quality Control, ideally in the exciting domain of cell therapy.
• Possesses a robust understanding and expertise in cGMP regulations and guidelines, along with a strong grasp of industry best practices for quality control.
• Demonstrates prior leadership experience in managing a team of talented QC professionals.
• Proven track record of successfully implementing and overseeing QC programs for cutting-edge cell therapy products.
• Outstanding leadership skills combined with exceptional communication and interpersonal abilities.
• Hands-on involvement in assay development, qualification, and validation for innovative cell therapy products.
• Thrives in a fast-paced and dynamic environment, with the ability to effectively manage multiple projects and priorities.

Benefits

• Competitive and flexible salary range.
• 401K plan.
• Industry leading full coverage health benefits.
• Flexible PTO and holiday shutdown.