Sr. Manager, Quality Science & Technology (CDx)

Role: Lead Design Quality Management for Companion Diagnostics (CDx), overseeing design assurance, risk management, and compliance activities across the portfolio. Responsibilities: manage a team supporting quality oversight of development processes, ensure adherence to design controls, support regulatory interactions, and maintain the Quality Management System (QMS). Collaborate with internal and external stakeholders, including pharma partners, to drive quality excellence and continuous improvement. Provide expertise in implementing regulations like ISO13485, FDA CFR 21 Part 820, and IVDR, ensuring product safety and regulatory compliance. Qualifications: Bachelor's or Master’s in a relevant field, 2+ years’ leadership experience in quality within regulated industries, with strong knowledge of medical device standards and IVD regulations. Preferred: experience in pharmaceutical or medical device industry, particularly in IVD/biotech settings. High-Value: focus on diagnostic device design, regulatory compliance, risk management, GxP, and cross-functional collaboration in a regulated environment. Work Setup: Full-time, day shift, with occasional travel; salary range $136,618-$213,465, plus bonus and benefits.