Lead Specialist, Quality, Digital

Role: Lead Digital Quality specialist providing quality oversight for software, cloud solutions, and digital platforms within biopharma, particularly supporting regulated non-medical-device software used in healthcare and digital health. Responsibilities: guide quality practices across product lifecycle stages—requirements, design, verification, validation, release, and change management; review documentation; support risk management, cybersecurity, and compliance; develop procedures and automate processes; train cross-functional teams; monitor quality metrics; support audits and investigations; and ensure adherence to evolving standards like ISO 13485, IEC 62304, and FDA software guidance. Requirements: Bachelor's in Engineering, CS, or Life Sciences (or 10+ years relevant experience); 6+ years in software quality, engineering, or regulatory compliance; experience with Agile, DevSecOps, and software lifecycle principles; strong technical writing and problem-solving skills. Preferred: experience in medical device or healthcare tech, cloud-native applications, SaaS, APIs, AI/ML software, and developing quality processes. High-Value: focus on digital health, cloud-based solutions, AI/ML, regulatory compliance, risk management, and software development in regulated environments. Collaboration with Product, Engineering, Regulatory, Cybersecurity, and Data teams; reporting line not specified. WorkSetup: not specified; no travel requirement stated.