US Site Quality Lead

The Director, Site Quality serves as the senior Quality leader for Advan Cell’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.

Quality Leadership & Strategy

• Serve as the senior Quality leader and member of the Site Leadership Team, contributing to site strategy, business planning, organizational development, and operational decision-making.
• Establish and execute the site Quality strategy, objectives, priorities, and roadmap aligned with corporate quality and business goals.
• Lead, develop, and mentor QA and QC teams, building a culture of quality, accountability, scientific rigor, continuous improvement, and employee engagement.
• Maintain the independence, authority, and integrity of the Quality organization in GMP decision-making.

Quality Management System (QMS)

• Ensure the development, implementation, maintenance, and continuous improvement of an effective, risk-based QMS appropriate for a Phase 3 and commercial manufacturing environment.
• Oversee core quality systems including deviations, CAPA, change control, investigations, complaints, risk management, supplier quality, document control, training, and management review.
• Lead Quality Review Boards, Change Control Boards, CAPA governance, and Management Review processes.
• Establish and monitor site quality metrics, quality plans, and performance indicators to identify trends, manage risk, and drive improvement.

GMP Operations & Product Quality

• Provide independent Quality oversight of the manufacture, testing, release, storage, and distribution of radiopharmaceutical products.
• Ensure effective systems for raw material, component, intermediate, finished product, and batch record review and disposition.
• Establish appropriate Quality oversight and release processes for clinical and commercial products.
• Review and approve GMP documentation, including procedures, specifications, investigations, change controls, validation protocols and reports, and quality agreements.
• Ensure product quality decisions are based on sound science, applicable regulations, approved procedures, and product specifications.

Quality Control Oversight

• Lead and oversee QC laboratory operations, including analytical testing, sampling, environmental monitoring, stability, and laboratory investigations.
• Ensure analytical methods, specifications, laboratory systems, equipment, and computerized systems are appropriately qualified, validated, and maintained.
• Ensure laboratory data…