Lead Specialist, Quality, Digital

Role: Lead Specialist in Digital Quality, providing expert guidance on quality practices for software products, cloud solutions, and digital platforms within a biopharma context. Responsibilities: oversee quality throughout software lifecycle stages, support non-medical and regulated digital health applications, evaluate product risks, review lifecycle documentation, implement scalable quality processes in Agile/DevSecOps environments, support risk management activities, participate in design and milestone reviews, develop quality procedures, train teams, monitor quality metrics, and support audits and investigations. Requirements: Bachelor's in Engineering, Computer Science, or related field; 6+ years in software quality, engineering, or digital product development; experience with Agile, Scrum, DevSecOps, and software lifecycle principles; strong documentation, analytical, and communication skills. Preferred: experience in regulated healthcare software, medical devices, cloud-native applications, AI/ML, and familiarity with standards like ISO 13485, IEC 62304, FDA software expectations, and cybersecurity. HighValue: focus on digital health, AI, cloud platforms, regulatory compliance, and risk management in a GxP or regulated environment. Work setup: not specified, but likely hybrid or remote based on industry norms; no travel specified.