Head of Quality (VP/SVP)

Career Opportunities with TScan Therapeutics A great place to work.   Careers At TScan Therapeutics Current job opportunities are posted here as they become available.     Back To Openings     Head of Quality (VP/SVP) Department: 13 - Quality Assurance Location: Waltham, MA START YOUR APPLICATION TScan Therapeutics is seeking a strategic, collaborative, and experienced VP/SVP, Head of Quality to lead the Company's Quality organization and establish a best-in-class quality culture that supports the development, manufacturing, and commercialization of innovative T cell therapies. Reporting directly to the Chief Executive Officer, the Head of Quality will serve as a key member of the senior leadership team and will provide executive oversight of all Quality functions, including Quality Assurance (QA), Quality Control (QC), Quality Systems, Validation, Supplier Quality, GMP Compliance, and GxP Quality oversight. This leader will ensure that quality systems effectively support both internal manufacturing operations and external manufacturing partners while maintaining compliance with global regulatory requirements. Beyond functional leadership, the Head of Quality will serve as an enterprise leader, partnering with executive colleagues to shape corporate strategy, assess organizational risk, enable operational excellence, and ensure quality is integrated into every stage of product development and manufacturing. The successful candidate will be an experienced biotechnology executive with a demonstrated ability to build and lead high-performing teams, influence cross-functional decision-making, and develop scalable quality systems in a fast-paced clinical and commercial environment. Key Responsibilities Develop and execute the Company's Quality vision and enterprise strategy, ensuring alignment with corporate objectives, regulatory expectations, and the Company's evolution from clinical-stage development to commercial readiness. Serve as the Company's senior Quality executive and trusted advisor to the CEO, Executive Leadership Team, and Board of Directors on quality strategy, compliance, enterprise risk, manufacturing readiness, and organizational priorities. Provide strategic leadership and oversight for the Quality organization, including Quality Assurance, Quality Control, Quality Systems, Validation, Supplier Quality, and GxP Compliance, building a scalable organization capable of supporting current operations and future growth. Champion a culture of quality, accountability, transparency, and continuous improvement by embedding quality principles into all aspects of the business and fostering cross-functional collaboration. Ensure the Company maintains an effective, scalable, and inspection-ready Quality Management System that supports compliance with global regulatory requirements and industry best practices. Oversee quality across internal GMP manufacturing operations and external manufacturing, testing, and supply partners, establishing strong governance, quality expectations, and proactive risk management throughout the product lifecycle. Serve as the Company's primary Quality representative during regulatory inspections, audits, and health authority interactions, ensuring organizational readiness and leading effective responses to regulatory observations and compliance matters. Partner closely with Technical Operations, Manufacturing, Research, CMC, Regulatory Affairs, Clinical Development, and other cross-functional leaders to ensure quality is integrated into product development, technology transfer, manufacturing, and commercialization strategies. Build, mentor, and develop a high-performing Quality organization by attracting exceptional talent, strengthening leadership capabilities, and creating a culture that supports employee growth, engagement, and succession planning. ...