Vice President, Quality

The Vice President, Quality is the senior Quality executive for SHINE's Nuclear Medicine business, with responsibility spanning both the SPECT diagnostic portfolio and the Ilumira Therapeutics product line, and is a member of the executive leadership team. The Vice President, Quality establishes the company-wide Quality vision, strategy, governance, and operating model across manufacturing operations in Massachusetts, Wisconsin, and Quebec. The role provides independent Quality oversight while partnering with Operations, Regulatory Affairs, Technical Operations, Engineering, Supply Chain, and Commercial to protect patients, employees, product quality, regulatory compliance, and continuity of supply.

The Vice President, Quality is the senior Quality executive for SHINE's Nuclear Medicine business, with responsibility spanning both the SPECT diagnostic portfolio and the Ilumira Therapeutics product line, and is a member of the executive leadership team. The Vice President, Quality establishes the company-wide Quality vision, strategy, governance, and operating model across manufacturing operations in Massachusetts, Wisconsin, and Quebec. The role provides independent Quality oversight while partnering with Operations, Regulatory Affairs, Technical Operations, Engineering, Supply Chain, and Commercial to protect patients, employees, product quality, regulatory compliance, and continuity of supply.

The Vice President, Quality will build and lead an integrated, high-performing Quality organization capable of supporting SHINE's SPECT and Ilumira Therapeutics product portfolios, technology transfer, supplier qualification, and future growth. The position is accountable for the effectiveness and continuous improvement of the Quality Management System (QMS), inspection readiness, product disposition governance, regulatory commitments, and quality culture across all sites. This position is based in Massachusetts and requires presence on-site three days per week.

• Enterprise Quality Strategy and Governance:
  Define and execute the Quality strategy for both the SPECT and Ilumira Therapeutics product lines, including a multi-year roadmap, annual objectives, and budget; design and maintain an integrated QMS with common standards and site-appropriate procedures; chair the Quality Management Review; and advise the CEO and executive team on significant quality and compliance risks.
• Quality Organization and Culture:
  Lead site Quality heads and enterprise Quality functions, with accountability for organization design, talent, performance management, and succession planning; build a culture in which Quality is an independent decision-maker and pragmatic business partner across the company.
• GxP and Product Quality Oversight:
  Provide executive oversight of batch record review, product disposition, deviations, investigations, CAPA, change control, complaints, recalls, and data integrity across SPECT diagnostic manufacturing as well as Ilumira active pharmaceutical ingredient (API) manufacturing, packaging, testing, release, and distribution.
• Regulatory Compliance and Inspection Readiness:
  Ensure compliance with applicable U.S. and Canadian pharmaceutical, nuclear, and radiation-safety requirements; maintain a sustained state of inspection readiness across all sites; and serve as the senior Quality representative with FDA, Health Canada, and other regulatory authorities, in coordination with Regulatory Affairs.
• Supplier and Contract Manufacturer Quality:
  Maintain robust governance for quality agreements, contract manufacturers, critical suppliers, and service providers, including oversight of supplier qualification activities in support of both the SPECT and Ilumira Therapeutics product portfolios.
• Integration, Growth, and Operational Excellence:
  Lead the Quality workstream for integrations, network harmonization, new supplier qualification, and business-transformation initiatives; define meaningful quality indicators and sponsor enterprise CAPA and continuous-improvement programs that protect supply and compliance.

• Approve or reject products, materials, processes,…