**Job Description Summary** 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. **Job Description** **Responsibilities** + **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** + **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** + **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** 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** 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** 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. \#LI-MG1 \#LI-HYBRID **Additional Information** **Relocation Assistance Provided:** No