R&D Compliance Leader

at  GE Healthcare

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 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.

REQUIREMENTS:

• 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.

• 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.