Vice President, Quality

Job Description

Job Description

Description:

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.

Requirements:

• 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.

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.

Working Conditions and Travel:

• Regular travel among Massachusetts, Wisconsin, and Quebec manufacturing locations, with additional domestic travel as business needs require; approximately 30-40% anticipated.
• Ability to work in controlled manufacturing, laboratory, cleanroom, and radiological environments in accordance with site safety, gowning, security, training, and dosimetry requirements.
• Availability outside standard business hours may occasionally be required to support time-sensitive product, inspection, safety, or supply matters.

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.

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Employee Rights Under the NLRA 

Equal Opportunity Employment