At a Glance
- Tasks: Lead compliance processes for clinical trials in pharmaceutical diagnostics and enhance quality systems.
- Company: Join a leading healthcare company committed to innovation and inclusion.
- Benefits: Competitive salary, professional development, and a diverse work environment.
- Other info: Collaborative team culture with opportunities for growth and independence.
- Why this job: Make a real impact on healthcare by ensuring compliance and quality in R&D.
- Qualifications: PhD, MSc, or BSc in a scientific field with experience in clinical research.
The predicted salary is between 60000 - 80000 £ per year.
The main purpose of this role is to establish and optimize processes that ensure the effective management of clinical trials within Pharmaceutical Diagnostics, 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.
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.
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.
Desired Characteristics
- 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, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
R&D Compliance Leader employer: GE Healthcare
At GE HealthCare, we pride ourselves on fostering a collaborative and inclusive work environment that empowers our employees to thrive. As an R&D Compliance Leader, you will have the opportunity to drive meaningful change in clinical trial management while benefiting from comprehensive training programs and career development initiatives. Our commitment to innovation and quality ensures that you will be part of a team dedicated to improving healthcare outcomes, all within a dynamic and supportive culture located at the forefront of pharmaceutical diagnostics.
StudySmarter Expert Advice🤫
We think this is how you could land R&D Compliance Leader
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their R&D processes and compliance standards so you can show off your knowledge and how you can contribute to their goals.
✨Tip Number 3
Practice your answers to common interview questions, especially those related to compliance and process improvement. We recommend doing mock interviews with friends or using online resources to boost your confidence.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace R&D Compliance Leader
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in clinical research and regulatory compliance. We want to see how your background aligns with the R&D Compliance Leader role, so don’t hold back on showcasing relevant skills!
Showcase Your Problem-Solving Skills:In your application, give examples of how you've tackled compliance issues or improved processes in past roles. We love a good story about overcoming challenges, especially if it relates to GxP or SOP management!
Be Clear and Concise:When writing your application, keep it straightforward and to the point. Use clear language to describe your achievements and experiences, as we appreciate clarity and precision in communication.
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at GE Healthcare
✨Know Your Compliance Stuff
Make sure you brush up on your knowledge of Good Practices (GxP) and relevant regulations. Be ready to discuss how you've navigated compliance issues in the past and how you can apply that experience to the role.
✨Showcase Your Process Improvement Skills
Prepare examples of how you've identified and implemented process improvements in previous roles. Highlight specific outcomes and how they enhanced quality or efficiency, as this will resonate well with the focus of the position.
✨Be Ready for Teamwork Questions
Since this role involves collaboration across departments, think of instances where you've successfully worked in a team. Be prepared to discuss how you communicate and resolve conflicts, as strong interpersonal skills are key.
✨Demonstrate Organisational Skills
Bring examples of how you've managed multiple priorities effectively. Discuss your strategies for staying organised and ensuring attention to detail, especially when it comes to maintaining compliance and documentation.
