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). Key Responsibilities Lead and advance the Device Quality strategy across the R&D and product lifecycle. Serve as accountable quality leader across development, clinical, and commercial stages. Define and execute global Device Quality strategy aligned to enterprise quality objectives. Maintain enterprise governance/oversight of all GxP Device activities. Partner with Precision Medicine, Clinical Development, Product Development, Global Business Unit, and Regulatory Affairs for co-development, validation, regulatory approval, and lifecycle management. Prepare Device Quality budget submissions and manage departmental spending. Ensure compliance with global device regulations/standards (FDA, EMA, ICH, ISO) and translate expectations into risk-based oversight. Ensure CLIA/CAP and global laboratory standard compliance (data integrity, method validation, change control, deviation management, inspection readiness). Oversee quality requirements for development, tech transfer, commercialization, performance monitoring, and post-market activities; investigate and document deviations. Own/continuously improve quality systems (design controls, risk management, supplier/external partner controls, complaints/vigilance, CAPA, post-market surveillance, laboratory quality systems). Lead Quality Council activities; manage notifications, health authority processes, and recall/recovery as needed. Qualifications Degree in science, engineering, or related field. 10–12+ years progressive Quality leadership supporting medical devices and/or combination products. In-depth knowledge of global regulatory requirements for medical devices/diagnostics. Proven experience with regulatory inspections/audits. Demonstrated ability interpreting FDA/EMA and foreign cGxP regulations. Strong communication/collaboration; team leadership and coaching; leadership/strategic thinking/problem-solving. Compensation & Benefits Compensation ranges: Devens, MA: $230,950 – $279,861 Madison, NJ: $215,850 – $261,558 New Brunswick, NJ: $215,850 – $261,558 Princeton, NJ: $215,850 – $261,558 Benefits include: Medical, dental, and vision coverage Wellbeing support 401(k) Disability and life insurance Application Instruction If you’re intrigued but don’t perfectly match, encourage to apply anyway. #J-18808-Ljbffr Scorpion Therapeutics