IT Transition and Transformation (T&T) in R&D

Seeking an experienced IT Transition Manager to lead end-to-end transition and outsourcing initiatives for product software in the Medical Device industry. The ideal candidate will orchestrate knowledge transfer, vendor management, and regulatory-compliant software transitions from development to external providers or between suppliers, ensuring quality, traceability, and on-time delivery.Responsibilities:Lead end-to-end transition programs for medical device software products (SW Applications, embedded, firmware, mobile platforms), including scope, plan, schedule, risk, and budget.Conduct performance management against agreed KPIs.Oversee knowledge transfer, documentation, validation/verification activities, and regulatory traceabilityCollaborate with QA, Regulatory, IT Security, Cybersecurity, Software Development, and Validation teams to ensure compliant software life cycle, change control, and risk management.Create and execute robust cutover and go-live plans; provide post-transition stabilization, issue resolution, and continuous improvement.Monitor program health, report progress to stakeholders, manage dependencies, risks, and budget; lead cross-functional teams and manage changes in scope.Must Haves:Extensive experience (10+ years) in IT transition and outsourcing within the medical device or tightly regulated industries.Deep knowledge of medical device software development life cycle (IEC 62304), risk management (ISO 14971), and quality systems (ISO 13485);Proven track record in vendor management, contract negotiation, SLAs, and governance for outsourced software products.Strong program management skills; ability to manage complex dependencies, budgets, and timelines; PMP or equivalent certification preferred.Excellent stakeholder management, communication, change management, and problem-solving abilities.Technical understanding of software development lifecycles, cybersecurity, data privacy considerations, and data migration activities.Bachelor’s degree in IT, Engineering, Computer Science, or a related field; advanced degree or relevant certifications a plus.Nice to haves:PMI certifications (PMP, PgMP, PMI-ACP) or ITIL; exposure to regulatory audits/inspections.Experience with QMS processes, CAPA, and quality metrics in a medical device context.Global experience with multi-site outsourcing and cross-cultural teams.Availability for travel as needed.Location/Travel:Hybrid/onsite options available; travel as required to manage transitions and vendor engagements.