Director, Quality & Regulatory, Digital Core Transformation

GE HealthCare • Arlington Heights, IL

9d

About The Position

Leads the Quality and Regulatory (Q&R) workstream for the Next Generation “Digital Core” transformation replacing key existing IT systems. Ensuring that all processes, data, and system capabilities enable compliant product realization and quality requirements. Partners with Q&R Process Owners (e.g., Design Controls, PPC/Product Hold, Supplier Quality, UDI) and other Functions/Program Leaders to help define requirements, validate solutions, and drive adoption while maintaining alignment to global Q&R expectations. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Requirements

• Bachelor’s degree and 8+ years of work experience – specifically in project / program management.
• Extensive experience in Quality and/or Regulatory roles within a regulated medical device and Drug environments.
• Strong working knowledge in multiple areas of the GE HealthCare Quality Systems and extensive use of these and/or related GE HealthCare IT Systems.
• Demonstrated leadership in cross-functional, enterprise-scale transformations (process, data, and/or business systems).
• Experience defining requirements and acceptance criteria and leading user testing/validation activities for enterprise systems impacting regulated processes.

Nice To Haves

• Familiarity with validation approaches for computerized systems and controlled configuration of enterprise tools used in regulated product realization.
• Strong program management, stakeholder management, and communication skills across global teams and leadership levels.
• Lean continuous improvement mindset with demonstrated ability to simplify processes, reduce variation, and drive adoption of standard work.
• Strong track record of digital transformation leadership in regulated environments (e.g., PLM, QMS, ERP/MES integrations), including process + data + people change.
• Deep understanding of quality systems and regulatory expectations and how they translate into scalable digital workflows (e.g., design controls, change management, post-market, complaints, risk management).
• Expertise in end-to-end product lifecycle thinking—connecting upstream design decisions to downstream manufacturing, service, and post-market outcomes.
• Ability to translate complex requirements into clear operating mechanisms: governance, decision rights, role clarity, escalation paths, and measurable outcomes.
• Data-driven mindset with experience defining and using leading indicators (quality, compliance, and process health) to steer priorities and investments.
• Strong executive presence with the ability to communicate succinctly to senior leaders and influence roadmap decisions.
• Skilled at building and sustaining cross-functional coalitions (e.g., Engineering, Regulatory, Quality, Supply Chain, Manufacturing, Service, Digital/IT).

Responsibilities

• Articulate Q&R requirements across the IT tools that will be impacted by this transformation
• Articulate Q&R requirements across PLM capabilities and item types, translating regulatory and quality system needs into clear system and process requirements.
• Represent Q&R as a cross-functional change champion: communicate impacts, align stakeholders, and drive adoption of standard work within Q&R and across segments.
• Define the Validation strategy with the Global CSV team to ensure consistency and appropriate level of qualification required
• Manage the holistic plans for Q&R involvement and resource requirements
• Own Q&R defect and enhancement intake: clarify problem statements, prioritize with program leadership, and ensure timely resolution/closure with documented rationale.
• Assess program and product alignment impacts (process, data, configuration, and controls) and escalate decisions or risks to the right forums for resolution.
• Support planning, execution, and delivery of PLM implementation scope by defining Q&R workstream deliverables, milestones, and readiness criteria.
• Coordinate cross-functionally (including IT and external consultants) to track timing, execution, and metrics for Q&R-related requirements, testing, and deployment.
• Provide periodic status, risks, and decision needs to Q&R and program leadership; ensure Q&R resourcing and budget needs are surfaced and managed.
• Help establish operating mechanisms within the Q&R workstream and across functions (cadence, issue escalation, and decision tracking).
• Collaborate with engineering, IT, product management, operations, and leadership to manage conflicts and drive commonality and standardization across segments.
• Coordinate with Capability Leads and Segment Subject Matter Experts (SMEs) to define and formulate complete, testable requirements including Q&R-specific attributes and control points.
• Define standard formats for requirement classifications and attributes, and ensure requirements are captured consistently in the chosen tool(s).
• Optimize use of PTC off-the-shelf capabilities while ensuring compliant configuration and controlled changes for regulated use cases.
• Drive lean methodology into program plans by mapping current-state processes, surfacing pain points, and identifying efficiency gains without compromising compliance.

Benefits

• Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities.
• Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
• GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
• GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.

What This Job Offers

• Job Type: Full-time
• Career Level: Director