NMDP

Manager

• Manages daily operations of Quality Assurance staff; implements and maintains enterprise quality system in support of strategic plan.
• Provides support and guidance to the organization regarding quality system and compliance with cell therapy regulations.
• Responsible for oversight of enterprise Quality Management software platform.
• Develops, improves and/or maintains processes and procedures for essential quality system elements, including change control, document control, internal audits, validations, supplier management, management reports, complaint and problem investigation/CAPA, etc.
• Evaluates business needs and ensures efficient and appropriate implementation of quality management software; proposes and manages changes, enhancements, and implementation of new functions.
• Leads and manages high-performing team responsible for internal audits, quality system reporting, change control oversight and approval, deviation and CAPA approval, validation oversight, and other QA functions.
• Provides support and guidance to business units and project teams regarding quality system and compliance with cell therapy regulations.

Manager, Quality

Solutions Engineer

• The Solution Architect plays a critical role in designing technical solutions that align with specific business needs and project goals.
• Develop end-to-end solution architectures that address business requirements, constraints, and non-functional needs (scalability, performance, security, reliability, usability).
• Create and maintain key architecture artifacts (e.g., context diagrams, logical and physical designs, data flow diagrams, integration patterns, API specifications).
• Ensure solutions align with enterprise architecture principles, technology standards, and reference architecture.
• Evaluate and select appropriate patterns (e.g., microservices, event-driven, layered architecture) and integration approaches (e.g., REST, messaging, FHIR, ETL, etc., if relevant).
• Lead or contribute to proof-of-concepts (POCs) and pilot projects to validate technical approaches.
• Recommend rationalization or modernization opportunities for legacy systems and integrations.
• Contribute to the evolution of the organization’s target architecture and technology roadmap.
• Work closely with Enterprise Architects to align tactical solutions with strategic IT vision.
• Partner with product owners, business analysts, and business stakeholders to understand strategy, objectives, and detailed requirements.
• Translate business and functional requirements into clear, actionable technical designs for engineering teams.
• Facilitate workshops and technical discussions to converge on solution approaches and trade-offs.
• Provide leadership and serve as a trusted advisor to both technical and non-technical stakeholders.
• Support transformation planning initiatives including cloud migration, external audits, and major business projects.
• Produce clear, concise architectural documentation and design decisions that can be understood by both technical and non-technical audiences.
• Maintain an up-to-date knowledge base of architecture patterns, standards, and solution templates.
• Mentor engineers and other team members in architectural practices, design thinking, and technical decision-making.