Quality and Compliance Leader at GE Healthcare

Eindhoven, North Brabant, Netherlands

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Medical TechnologyIndustries

Requirements

Relevant academic degree or academic level obtained by working experience in Life Sciences
Minimum of 5 years demonstrated knowledge and experience in pharmaceutical industry regulations, including GMP Eudralex Annex 1 and data integrity guidelines
Experience with Quality Management System tools, equipment qualifications, and continuous improvement methodologies
Experience in conducting audits to verify adherence to cGMP guidelines
Fluent Dutch
Work location in Eindhoven

Responsibilities

Key member of the Quality Leadership Team contributing to the overall success and direction of the Eindhoven site
Ensure full quality and regulatory compliance of the facility, while driving process effectiveness and efficiency at the site
Proactively identify and address potential quality and compliance issues, working collaboratively with cross functional teams to implement preventive measures
Collaborate and lead/integrate quality activities and considerations for site expansion and change activities
Work with Manufacturing, Engineering, Validation and NPI teams to drive changes that will reduce quality issues and result in higher long-term reliability
Lead and coordinate change projects from Global Quality at the Eindhoven site to ensure future readiness
Proactively lead and support (site) projects and process improvement initiatives from a Quality perspective
Lead and support critical investigations and problem-solving on site as needed
Utilize data driven insights to identify trends, root causes and areas for improvement
Drive risk reduction proactively leveraging the site risk register
Benchmark other sites and industry standards to drive best in class practices
Ensure the site and business are fully prepared for external and internal compliance inspections, aiming for non-systemic results and no critical findings; collaborate closely with business partners to maintain audit readiness at all times
Have external focus to understand business and Quality trends in the global supply chain and implement best practices in Eindhoven site
Identify skills and competency gaps in the quality teams, providing leadership and direction within own functional remit
Improve and promote a strong Quality Culture across the site
Comply with Environment, Health & Safety (EHS) Policies and applicable laws and regulations

Skills

Quality Assurance

Regulatory Compliance

Continuous Improvement

Leadership

Process Optimization

Cross-Functional Collaboration

QA/QC

GE Healthcare

Healthcare technology and data analytics provider

About GE Healthcare

GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.

Chicago, IllinoisHeadquarters

1892Year Founded

N/ACompany Stage

Data & Analytics, HealthcareIndustries

10,001+Employees

Risks

Emerging AR technologies increase competition in medical imaging.

Regulatory challenges may delay AI application expansions in healthcare.

Dependence on clinical trial success for new product market positioning.

Differentiation

GE Healthcare invests $1 billion annually in R&D for product innovation.

The company supports over 300,000 patients daily with its healthcare technologies.

GE Healthcare's AIR Recon DL offers 3D motion-insensitive imaging for enhanced MRI quality.

Upsides

Acquisition of Caption Health expands AI-powered ultrasound capabilities.

Successful Phase III trial of [18F]flurpiridaz enhances coronary artery disease detection.

Collaboration with Wayra accelerates digital health innovation in EMEA.

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