QA Manager Regional Quality PDx, USA

Job Description Summary

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Has in-depth knowledge of best practices and how own area integrates with others; has working knowledge of competition and the factors that differentiate them in the market

Job Description

Leadership & People Management

• Lead, coach, and develop Regional Quality team members supporting the U.S. market, ensuring operational excellence, regulatory compliance, customer focus, and effective execution of Quality responsibilities.
• Drive engagement, clarity, accountability, and strong cross-functional collaboration across a geographically dispersed organization.
• Foster a strong Quality and compliance culture across internal operations and external distribution partners.

Regional Quality & Compliance Oversight

• Provide Quality leadership and governance for U.S. Regional Quality activities, with primary focus on radiopharmaceutical products and distribution operations, and support Contrast Media as needed.
• Provide oversight of the regional Quality Management System and ensure alignment with the Global QMS and applicable U.S. regulatory requirements.
• Ensure compliance with applicable FDA requirements, cGMP, GDP (distribution requirements), product-specific controls, state requirements where applicable, and company Quality standards.
• Provide Quality oversight across the product distribution lifecycle, including receipt, storage, handling, transportation, distribution, returns, recalls, and disposition activities, as applicable.
• Ensure appropriate oversight of time- and temperature-sensitive radiopharmaceutical distribution, including maintenance of required product handling and distribution controls.
• Identify, assess, communicate, and escalate Quality and compliance risks to regional and business leadership.

Radiopharmaceutical Distribution Quality

• Provide Quality oversight for the distribution of radiopharmaceutical products within the U.S. market, including internal operations, distribution locations, logistics providers, and other outsourced activities.
• Ensure distribution processes maintain product quality, integrity, traceability, security, and compliance throughout the supply chain.
• Oversee Quality requirements related to transportation, temperature excursions, distribution deviations, product complaints, returns, recalls, and other distribution-related Quality events.
• Partner closely with Supply Chain, Operations, Regulatory Affairs, Pharmacovigilance, Medical, Commercial, and other functions to ensure effective management of Quality risks.
• Support qualification, monitoring, and Quality governance of third-party logistics providers, distributors, suppliers, and other external partners.
• Support Contrast Media distribution and Quality activities as required based on business priorities and regional needs.

Quality System Performance & Continuous Improvement

• Establish and monitor regional Quality objectives, KPIs, trends, and performance metrics.
• Ensure timely and effective investigation, documentation, approval, and closure of deviations, CAPAs, complaints, change controls, temperature excursions, and other Quality records.
• Ensure effectiveness of corrective and preventive actions and identify recurring or systemic Quality issues through trending and management review.
• Drive simplification, standardization, and continuous improvement of Regional Quality processes.
• Participate in global and regional Quality initiatives and share best practices across the Pharmaceutical Diagnostics organization.

Inspection & Regulatory Readiness

• Maintain inspection readiness for U.S. Regional Quality and distribution activities.
• Support and participate in regulatory inspections, internal audits, supplier/distributor audits, and other Quality assessments.
• Represent Regional Quality during interactions with regulatory authorities and other external parties, as appropriate.
• Ensure observations, nonconformities, and audit findings are appropriately investigated and corrective actions are completed effectively and on time.

Quality Governance & Business Partnership

• Serve as a senior Quality partner to U.S. Regional, Supply Chain, Operations, Regulatory, and Commercial leadership.
• Provide independent Quality oversight and appropriate escalation of significant Quality, compliance, product, or distribution risks.
• Balance regulatory and Quality requirements with operational needs while ensuring patient safety, product quality, and compliance remain the primary considerations.
• Communicate Quality performance, emerging risks, inspection readiness, and significant Quality events to leadership.

Required Qualifications

• Master's degree from an accredited university or college; or bachelor's degree and 2 years of relevant experience; or a high school diploma/GED with at least 6 years or relevant experience.

Desired Characteristics

• Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects. Ability to document, plan, market, and execute programs. Established project management skills.

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 $122,400.00-$183,600.00 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 location. In 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.