• Develop, execute, and track remediation plans to address potential compliance gaps identified through due diligence, audits, or regulatory findings • Support remediation of legacy systems to meet compliance expectations • Partner with functions to lead remediation of Design History Files (DHFs), Technical Documentation, Risk Management Files, and labeling as required • Identifies critical path decisions, makes recommendations, and influences / gets buy-in from segment leadership and business process owners to maximize QMS integration, compliance and effectiveness • Provide clear communication of remediation status, risks, and timelines to leadership • Owns all project risk; including time and scope, and the associated plans to contain and/or mitigate risk • Coordinates Operational Reviews working across the organization to ensure targeted outcomes are achieved • Supports external and internal audit activity as needed

• Lead and coordinate the activities of cross-functional teams (marketing, sales, regulatory, medical, and supply chain) to ensure alignment and timely execution of the product launch plan. • Develop and manage comprehensive project plans, including timelines, deliverables, and key milestones, to ensure a successful launch of the new product in the designated category. • Work with functional leads to prioritize tasks and allocate resources effectively to meet project deadlines and business goals. • Identify potential risks, develop mitigation strategies, and ensure proactive resolution of issues that could impact the launch timeline or project success. • Serve as the primary point of contact for all project-related communications, providing regular updates to senior leadership and key stakeholders on project progress, risks, and mitigation plans. • Monitor project budgets and financial performance, ensuring that all activities are delivered on time and within budget. • Ensure that all aspects of the launch adhere to regulatory requirements and corporate quality standards. • Post-launch, evaluate the project’s success, document lessons learned, and implement process improvements for future product launches.

• Lead complex, cross-functional programs spanning Sales, Customer Success, Professional Services, Data teams and other functional areas • Translate business strategy into executable operational roadmaps with clear milestones, ownership, and success metrics • Drive alignment across stakeholders with competing priorities, ensuring timely delivery and measurable impact • Proactively identify risks, dependencies, and constraints; develop mitigation plans and escalation paths • Assess end-to-end processes (lead-to-cash, onboarding, delivery, renewals, data flows) to identify inefficiencies, bottlenecks, and root causes • Apply Lean Six Sigma methodologies (Process mapping, Kaizen, value stream mapping, root cause analysis) to design and implement scalable process improvements • Standardize workflows, documentation, and operating cadences while balancing flexibility for growth • Measure outcomes and ensure improvements are sustained through governance, controls, and feedback loops • Drive adoption of new processes, tools, and ways of working through thoughtful change management • Partner with functional leaders to develop communication, training, and enablement plans • Act as a trusted advisor to stakeholders, influencing without authority and fostering a culture of operational rigor and continuous improvement

• Provide leadership supporting transition and execution readiness following contract award. • Support development of integrated program governance structures, performance metrics, and reporting frameworks. • Provide guidance for agile delivery, sprint execution, and cross-functional team integration. • Support the development of project schedules, risk management plans, and operational delivery models. • Collaborate with customer stakeholders to ensure alignment with Enterprise Performance Life Cycle (EPLC), CDC governance requirements, and NIST/NICE workforce standards. • Support coordination across multidisciplinary teams, including developers, architects, cybersecurity engineers, and data scientists.