At a Glance
- Tasks: Conduct audits to ensure clinical trial data accuracy and compliance with regulations.
- Company: Join CSL Seqirus, a leading global influenza vaccine provider.
- Benefits: Enjoy competitive benefits, including health support and opportunities for professional growth.
- Other info: Collaborative culture focused on inclusion and belonging, with excellent career advancement opportunities.
- Why this job: Make a real impact on clinical research integrity while working in a dynamic environment.
- Qualifications: BS degree in biological science and experience in quality assurance within clinical trials.
The predicted salary is between 40000 - 50000 £ per year.
Quality in clinical development is a matter of operational resilience as much as regulatory mandate. This role serves as a CQA Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of clinical trial data and compliance with legal and corporate standards. By conducting audits of our clinical investigator sites, external vendors, and internal trial management processes, you identify the findings and non-compliance trends that could impact the integrity of our clinical research. We are looking for an experienced auditor who can navigate complex clinical environments and work collaboratively with stakeholders to develop corrective actions that ensure long-term systemic stability.
Main Responsibilities
- Audit Execution: Conduct assigned external audits of clinical investigator sites, Contract Research Organizations (CROs), E-System providers, and Institutional Review Boards (IRBs/ECs).
- Reporting & Risk Categorization: Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to trial conduct and data integrity.
- Trend Analysis: Identify non-compliance trends and systematic risks within the Clinical (GCP) discipline, communicating these findings to line management and clinical functional leads to ensure trial robustness.
- Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions for clinical trial management and monitoring.
- Regulatory Knowledge: Maintain up-to-date knowledge of global GCP regulations (ICH E6) and industry trends, identifying new requirements to ensure a high level of quality is maintained across all clinical development programs.
Position Qualifications & Experience
- Academic Background: BS degree in a relevant biological science, science, or related discipline.
- Professional Experience: Quality Assurance experience within a GCP-regulated environment, demonstrating a strong understanding of clinical trial phases, monitoring, and regulatory frameworks.
- Audit Expertise: Experience in clinical audit and inspection management, with a clear understanding of the requirements for quality assurance in the clinical research discipline.
- Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational clinical teams, investigators, and external CROs.
- Organizational Agility: Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% global travel.
Auditor - CQA in Reading employer: CSL Seqirus
CSL Seqirus in Liverpool is an exceptional employer, offering a vibrant work culture that prioritises professional growth and development. As a leader in the pharmaceutical industry, we provide our employees with unique opportunities for mentorship and continuous learning, all while ensuring adherence to the highest quality standards in a supportive and innovative environment.
StudySmarter Expert Advice🤫
We think this is how you could land Auditor - CQA in Reading
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field and let them know you're on the lookout for auditor roles. 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 brushing up on your knowledge of GCP regulations and audit processes. We recommend creating a list of common interview questions related to auditing and practicing your responses. Confidence is key!
✨Tip Number 3
Showcase your audit expertise by sharing specific examples from your past experiences during interviews. Highlight how you've identified non-compliance trends and implemented corrective actions. This will demonstrate your value to potential employers.
✨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 Auditor - CQA in Reading
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in quality assurance and clinical audits. Use keywords from the job description to show that you understand what we're looking for.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Share specific examples of how you've navigated complex clinical environments and worked with stakeholders. We want to see your personality and passion for the role.
Showcase Your Regulatory Knowledge:Since this role involves maintaining up-to-date knowledge of GCP regulations, mention any relevant training or certifications you have. This will demonstrate your commitment to quality in clinical development.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at CSL Seqirus
✨Know Your GCP Regulations
Make sure you brush up on the latest global Good Clinical Practice (GCP) regulations, especially ICH E6. Being able to discuss these in detail will show that you’re not just familiar with the rules but also committed to maintaining high standards in clinical research.
✨Prepare for Audit Scenarios
Think about potential audit scenarios you might face in this role. Prepare examples from your past experience where you identified non-compliance or developed corrective actions. This will demonstrate your practical knowledge and problem-solving skills during the interview.
✨Showcase Your Communication Skills
Since this role involves working with various stakeholders, practice articulating your thoughts clearly and confidently. You might be asked how you would handle difficult conversations or negotiate with external partners, so have a few strategies ready to share.
✨Highlight Your Organisational Agility
Be ready to discuss how you manage your time and priorities, especially with the potential for global travel. Share specific examples of how you've successfully navigated complex environments and adapted to changing circumstances in previous roles.
