US Site Quality Lead

The Director, Site Quality serves as the senior Quality leader for AdvanCell’s Andover manufacturing site and is responsible for the leadership, performance, and continuous improvement of all site Quality Assurance (QA) and Quality Control (QC) functions. Reporting to the VP, Global Head of Quality and serving as a member of the Site Leadership Team, the role provides strategic and operational leadership to ensure the effectiveness of the site Quality Management System (QMS) and compliance with applicable regulatory, GMP, radiation safety, and corporate quality requirements.

The Director, Site Quality is responsible for maintaining the independence, integrity, and effectiveness of the Quality organization while enabling the reliable manufacture, testing, release, and distribution of clinical and commercial radiopharmaceutical products. The role oversees Quality Systems, batch disposition and release, QC laboratory operations, validation and qualification oversight, supplier and external partner quality, inspection readiness, quality risk management, and continuous improvement.

As the Andover site progresses from construction and Phase 3 clinical manufacturing into commercial operations, this leader will establish and mature the site Quality organization, build a strong quality culture, and implement scalable systems and processes capable of supporting increasing manufacturing complexity, regulatory expectations, and business growth.

The Director, Site Quality will partner closely with Manufacturing, MSAT, Supply Chain, Regulatory Affairs, Clinical Operations, Engineering, EHS/Radiation Safety, Corporate Quality, and other functions, as well as external contract manufacturing organizations, testing laboratories, suppliers, and logistics providers.

As a member of the Site Leadership Team, the Director contributes to strategic planning, organizational development, risk management, and cross-functional decision-making. The role will provide independent Quality leadership while enabling the business to achieve its objectives and successfully transition the Andover site from startup through clinical manufacturing and into commercial GMP operations.