TScan Therapeutics is seeking a strategic collaborative and experienced VPSVP Head of Quality to lead the Companys 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 Companys Quality vision and enterprise strategy ensuring alignment with corporate objectives regulatory expectations and the Companys evolution from clinical stage development to commercial readinessServe as the Companys 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 prioritiesProvide 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 growthChampion a culture of quality accountability transparency and continuous improvement by embedding quality principles into all aspects of the business and fostering cross functional collaborationEnsure the Company maintains an effective scalable and inspection ready Quality Management System that supports compliance with global regulatory requirements and industry best practicesOversee 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 lifecycleServe as the Companys primary Quality representative during regulatory inspections audits and health authority interactions ensuring organizational readiness and leading effective responses to regulatory observations and compliance mattersPartner 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 strategiesBuild 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 planningFoster strong collaborative relationships with external partners contract manufacturers laboratories and suppliers to ensure alignment on quality expectations operational excellence and successful execution of strategic initiativesDrive operational excellence by leveraging quality metrics risk based decision making and continuous improvement initiatives to enhance compliance efficiency and organizational performanceLead the Quality organization with an enterprise mindset balancing scientific rigor regulatory compliance business objectives and patient focus to support TScans mission and long term successQualifications Education Bachelors degree in Life Sciences Engineering Pharmacy or related discipline requiredAdvanced degree MS PhD PharmD or MBA preferredExperience Minimum of 15 years of progressive Quality leadership experience within biotechnology or pharmaceutical industriesSignificant executive leadership experience in GMP manufacturing environments supporting biologics cell therapy gene therapy or other advanced therapies strongly preferredDemonstrated experience overseeingQuality AssuranceQuality ControlQuality SystemsValidationSupplier QualityGMP ComplianceExperience supporting both internal manufacturing operations and external manufacturing organizations CMOsCDMOs strongly preferredProven success leading organizations through FDA and international regulatory inspectionsExperience supporting products from clinical development through commercialization is highly desirableStrong knowledge of FDA EMA ICH PICS and global GxP regulations