Vice President, Quality

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 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.

This position is based in Massachusetts and requires presence on-site three days per week.

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.

Decision Rights and Quality Authority

• Approve or reject products, materials, processes, suppliers, quality systems, and GMP facilities within the scope defined by applicable procedures and licenses.
• Stop or suspend manufacturing, testing, release, distribution, or other regulated activity when continued operation presents an unacceptable quality, safety, or compliance risk.
• Require investigation, containment, correction, CAPA, or additional verification before an activity resumes or a product is released.
• Escalate unresolved quality, patient-safety, or compliance matters directly to the CEO and, when appropriate, to the designated Board committee.
• Delegate operational Quality decisions to qualified Quality leaders while retaining executive accountability for the overall effectiveness of the Quality organization and QMS.

Requirements

• Bachelor's degree in chemistry, pharmacy, engineering, life sciences, nuclear science, or a related discipline; advanced degree a plus (e.g., MS, MBA, PhD).
• 15+ years of progressive Quality, compliance, or regulated manufacturing experience, including substantial leadership responsibility in pharmaceuticals, radiopharmaceuticals, medical isotopes, or another highly regulated life-sciences environment.
• 10+ years leading managers and multidisciplinary Quality teams, including responsibility for organization design, talent development, budgets, and enterprise priorities.
• Demonstrated experience leading Quality across multiple manufacturing sites and influencing executive-level business decisions.
• Deep working knowledge of current good manufacturing practice and pharmaceutical quality systems, including applicable FDA requirements, Health Canada expectations, ICH guidance, USP standards, and data-integrity principles.
• Experience supporting regulatory inspections and significant customer audits, including response development, remediation, and sustained inspection readiness.
• Experience with commercial product disposition, laboratory operations, validation, supplier quality, and complex investigations/CAPA.
• Executive Quality leadership in radiopharmaceutical, nuclear medicine, isotope production, or related operations preferred, including experience spanning both diagnostic (SPECT) and therapeutic radiopharmaceutical or active pharmaceutical ingredient (API) manufacturing.
• Experience overseeing both U.S. and Canadian regulated manufacturing operations and working with nuclear or radiation-safety regulators preferred.
• Experience integrating acquired operations and harmonizing previously independent quality systems across a manufacturing network preferred.

SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.

SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.