Senior Director Device Quality

Position Summary The Senior Director, Device Quality provides global strategic leadership and accountability for quality across medical devices, drug-device combination products, companion diagnostics (CDx), and precision medicine-enabling platforms (including CLIA-certified laboratory operations). Responsibilities Lead and advance Device Quality strategy across the R&D and product lifecycle; accountable quality leader across development, clinical, and commercial stages. Define/execute global Device Quality strategy aligned to enterprise objectives; maintain enterprise GxP governance for device activities. Partner with Precision Medicine, R&D, Clinical Development, Regulatory Affairs, Global/External Manufacturing, and Commercial to embed quality by design; support co-development, validation, regulatory approval, and lifecycle management. Ensure compliance with global device regulations/standards (e.g., FDA, EMA, ICH, ISO); interpret evolving expectations and translate into risk-based oversight. Ensure CLIA/CAP and laboratory standards compliance (data integrity, method validation, change control, deviations, inspection readiness) and frameworks for CDx/IVDR. Own and improve quality systems (design controls, risk management, supplier/external partner controls, complaint handling/vigilance, CAPA, post-market surveillance, lab quality). Lead Quality Council activities; notify senior management of significant quality issues; support defect reporting, health authority notifications, and product recall/recovery. Oversee device quality systems/documentation; drive continuous improvement; embed ALCOA+ and quality risk management. Qualifications Degree in science/engineering/related field. 10–12+ years progressive quality leadership experience supporting medical devices/combination products. In-depth global regulatory knowledge; proven experience with regulatory inspections/audits; strong FDA/EMA and foreign cGxP interpretation. Compensation (US locations) Devens, MA: $230,950–$279,861 Madison/Giralda, NJ: $215,850–$261,558 New Brunswick, NJ: $215,850–$261,558 Princeton, NJ: $215,850–$261,558 Additional incentive cash/stock may be available (based on eligibility). Benefits Health coverage Wellbeing support 401(k) Disability Life/Accident insurance Supplemental health Travel protectionLegal support #J-18808-Ljbffr