Job Description Summary

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.

Job Description

Roles and 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.

Required Qualifications

• Bachelors 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.

Desired Characteristics

• 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 thinkingconnecting 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).

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.

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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.

We will not sponsor individuals for employment visas now or in the future for this job opening. For U.S. based positions only the pay range for this position is $142400.00-$213600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills qualifications experience and addition this position may also be eligible to earn performance based incentive compensation which may include cash bonus(es) and/or long term incentives (LTI). 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.

Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19 some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.