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.
- Foster strong, collaborative relationships with external partners, contract manufacturers, laboratories, and suppliers to ensure alignment on quality expectations, operational excellence, and successful execution of strategic initiatives.
- Drive operational excellence by leveraging quality metrics, risk-based decision making, and continuous improvement initiatives to enhance compliance, efficiency, and organizational performance.
- Lead the Quality organization with an enterprise mindset, balancing scientific rigor, regulatory compliance, business objectives, and patient focus to support TScan's mission and long-term success.
QualificationsEducation - Bachelor's degree in Life Sciences, Engineering, Pharmacy, or related discipline required.
- Advanced degree (MS, PhD, PharmD, or MBA) preferred.
Experience - Minimum of 15 years of progressive Quality leadership experience within biotechnology or pharmaceutical industries.
- Significant executive leadership experience in GMP manufacturing environments supporting biologics, cell therapy, gene therapy, or other advanced therapies strongly preferred.
- Demonstrated experience overseeing:
- Quality Assurance
- Quality Control
- Quality Systems
- Validation
- Supplier Quality
- GMP Compliance
- Experience supporting both internal manufacturing operations and external manufacturing organizations (CMOs/CDMOs) strongly preferred.
- Proven success leading organizations through FDA and international regulatory inspections.
- Experience supporting products from clinical development through commercialization is highly desirable.
- Strong knowledge of FDA, EMA, ICH, PIC/S, and global GxP regulations.
