Vice President of Quality and Regulatory Affairs
San Francisco Bay Area (Hybrid)
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Our client is a cutting edge CAR-T who novel approach dramatically decreases the time and cost associated with manufacturing. This is a newly created position allowing you to get in on the ground floor and eventually build a team beneath you as their indications advance in development.
If you are looking to be at the forefront of revolutionizing the CAR-T cell therapy space don't hesitate to apply and learn more.
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Job Summary: As the Vice President of Quality and Regulatory Affairs you will play a pivotal role in ensuring the quality, safety, and compliance of our CAR-T therapies throughout their lifecycle. You will lead the development and implementation of quality and regulatory strategies, establishing processes that adhere to global regulatory requirements and industry best practices. With a focus on continuous improvement, you will drive a culture of quality excellence across the organization, fostering collaboration between quality assurance, regulatory affairs, and other functional areas.
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Key Responsibilities:
Develop and execute a comprehensive quality and regulatory strategy aligned with the company's goals and objectives for CAR-T therapies.
Establish and maintain quality management systems (QMS) to ensure compliance with relevant regulations, standards, and guidelines (e.g., FDA, EMA, ICH).
Oversee the preparation and submission of regulatory filings, including INDs, BLAs, and marketing applications, ensuring timely approvals and compliance with regulatory requirements.
Serve as the primary interface with regulatory agencies, representing the company in interactions, meetings, and inspections.
Lead risk management activities, identifying potential quality and regulatory risks and implementing mitigation strategies.
Drive the development and implementation of robust processes for product manufacturing, testing, and release, ensuring product quality and consistency.
Collaborate cross-functionally with R&D, Clinical Development, Manufacturing, and Commercial teams to support product development, clinical trials, and commercialization activities.
Provide oversight of contract manufacturing organizations (CMOs) and other external partners to ensure compliance with quality and regulatory requirements.
Stay abreast of evolving regulatory trends, guidelines, and standards relevant to cellular therapies and proactively assess their impact on the company's operations and strategies.
Lead and support internal and external audits, ensuring timely resolution of findings and implementation of corrective and preventive actions (CAPAs).
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Qualifications:
Experience with CAR-T therapies preferred.
Experience with Cell Therapies is also acceptable.
Experience with IND filings.
Leadership experience in quality and regulatory.
Interaction with Health Authorities.
