Vice President, Quality
HybridNorth Billerica, Massachusetts, United States
Job Summary
Define and execute the company-wide Quality vision, strategy, and governance across manufacturing operations in Massachusetts, Wisconsin, and Quebec. Lead an integrated Quality organization while providing independent oversight of batch record review, product disposition, deviations, investigations, CAPA, and data integrity for both SPECT diagnostic and Ilumira therapeutic portfolios. Ensure compliance with U.S., Canadian, and nuclear regulatory requirements, maintaining sustained inspection readiness and serving as the senior representative to FDA and Health Canada. Manage supplier qualification, contract manufacturers, and business-transformation initiatives to protect patient safety and supply continuity. Requires on-site presence three days per week with 30-40% travel among sites.
Required Qualifications
- Bachelor's degree in chemistry, pharmacy, engineering, life sciences, nuclear science, or a related discipline
- Advanced degree (MS, MBA, PhD)
- 15+ years of progressive Quality, compliance, or regulated manufacturing experience
- Substantial leadership responsibility in pharmaceuticals, radiopharmaceuticals, medical isotopes, or another highly regulated life-sciences environment
- 10+ years leading managers and multidisciplinary Quality teams
- Responsibility for organization design, talent development, budgets, and enterprise priorities
- Demonstrated experience leading Quality across multiple manufacturing sites
- Influencing executive-level business decisions
- Deep working knowledge of current good manufacturing practice and pharmaceutical quality systems
- Knowledge of applicable FDA requirements
- Knowledge of Health Canada expectations
- Knowledge of ICH guidance
- Knowledge of USP standards
- Knowledge of data-integrity principles
- Experience supporting regulatory inspections and significant customer audits
- Experience with response development, remediation, and sustained inspection readiness
- Experience with commercial product disposition
- Experience with laboratory operations
- Experience with validation
- Experience with supplier quality
- Experience with complex investigations/CAPA
- Executive Quality leadership in radiopharmaceutical, nuclear medicine, isotope production, or related operations
- Experience spanning both diagnostic (SPECT) and therapeutic radiopharmaceutical or active pharmaceutical ingredient (API) manufacturing
- Experience overseeing both U.S. and Canadian regulated manufacturing operations
- Working with nuclear or radiation-safety regulators
- Experience integrating acquired operations
- Experience harmonizing previously independent quality systems across a manufacturing network
- Regular travel among Massachusetts, Wisconsin, and Quebec manufacturing locations
- Additional domestic travel as business needs require
- Approximately 30-40% anticipated travel
- Ability to work in controlled manufacturing, laboratory, cleanroom, and radiological environments
- Adherence to site safety, gowning, security, training, and dosimetry requirements
- Availability outside standard business hours
Desired Qualifications
- Advanced degree (MS, MBA, PhD)
- Executive Quality leadership in radiopharmaceutical, nuclear medicine, isotope production, or related operations
- Experience spanning both diagnostic (SPECT) and therapeutic radiopharmaceutical or active pharmaceutical ingredient (API) manufacturing
- Experience overseeing both U.S. and Canadian regulated manufacturing operations
- Working with nuclear or radiation-safety regulators
- Experience integrating acquired operations
- Experience harmonizing previously independent quality systems across a manufacturing network
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