Job Description

Summary

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The main purpose of this role is to establish and optimize processes that ensure the effective management of clinical trials within Pharmaceutical Diagnostics, Imaging R&D. The position also focuses on enhancing the overall quality of systems and processes in pharmaceutical diagnostic research by identifying and resolving compliance issues.



GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. 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.

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Responsibilities

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Process Development and Optimization

: Identify and establish processes that are 'fit for purpose' to support Pharmaceutical Diagnostics (PDx) R&D programs, focusing on clinical trials.

Regulatory Compliance

: Ensure business growth by simplifying processes and maintaining compliance with evolving regulatory environments. This includes creating new Standard Operating Procedures (SOPs) and rolling them out to relevant teams.

Quality Enhancement

: Identify and address compliance issues across R&D systems and processes to strengthen quality and maintain regulatory inspection readiness.

SOP Management

: Oversee and maintain the review cycle for R&D SOPs, working within the compliance team and collaborating cross-functionally with other departments as needed.

Good Practices (GxP) Adherence

: Ensure that all R&D activities adhere to relevant Good Practices (GxP) and Standard Operating Procedures (SOPs).

Training Oversight

: Support functional managers in training staff appropriately for their roles and ensure that training records are maintained as required.

Compliance Reporting

: Provide reporting metrics to disseminate compliance information across R&D teams.

Audit Support

: Contribute to the GxP audit schedule in collaboration with relevant R&D teams and Quality Assurance (QA). Lead and/or support GxP audits for both Contract Research Organizations (CROs) and internal departments.

Regulatory Inspection Support

: Assist with regulatory inspections and audits, including preparation, conduct, corrective/preventative action, and follow-up.

Process Improvement

: Proactively identify and implement process improvement initiatives within the R&D function.

Risk Management

: Collaborate with functional teams to identify and monitor risks, manage them within cost, quality, and time parameters, and develop contingency plans.

GxP Expertise

: Provide GxP expertise and advice to study and functional teams as needed.

GxP Archivist

: May act as a designated GxP Archivist or deputy as required.

Document Management

: Assist with the maintenance of the Document Management System (eTMF and Quality Vault), including upgrades, routine releases, access control, and training.

Qualifications

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Educational Background

: PhD, MSc, or BSc in a scientific/medical discipline.

Experience

: Several years of experience in Clinical Research, Research, or an equivalent field.

Regulatory Knowledge

: A strong understanding of relevant Health Authority regulations, guidance, and the drug development process.

Technical Skills

: Ability to read and comprehend technical documentation, execute procedures, and understand system documentation.

Organizational Skills

: Strong organizational skills with high attention to detail.

Computer Proficiency

: Familiarity with industry-standard computerized system applications.

Desired Skills

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Teamwork

: Strong teamwork, communication, and interpersonal skills.

Problem-Solving

: Demonstrable problem-solving abilities.

Process Improvement Mindset

: A strong passion for quality and a mindset focused on continuous process improvement.

Multi-tasking

: Ability to manage multiple priorities effectively and work well under pressure and time constraints.

Document Management Systems Experience

: Experience with Veeva or other document/information management systems is desired.

Independence

: Ability to work independently with minimal supervision.

Inclusion and Diversity

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GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, g ender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

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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.

Total Rewards

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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.


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Additional Information

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Relocation Assistance Provided:

No