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- 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 a focus on well-being.
- Other info: Dynamic role with opportunities for global travel and professional growth.
- Why this job: Make a real impact in clinical research while ensuring quality and compliance.
- Qualifications: BS degree in biological science and experience in quality assurance within GCP.
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 Maidenhead employer: CSL Plasma
Contact Detail:
CSL Plasma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Auditor - CQA in Maidenhead
✨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. Be ready to discuss how you've tackled compliance issues in the past and how you can contribute to maintaining high-quality standards at CSL Seqirus.
✨Tip Number 3
Showcase your analytical skills! During interviews, highlight specific examples where you've identified non-compliance trends and implemented corrective actions. This will demonstrate your ability to enhance operational resilience in clinical environments.
✨Tip Number 4
Don't forget to apply through our website! It's the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in joining CSL Seqirus and being part of our mission to improve global health.
We think you need these skills to ace Auditor - CQA in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Auditor role. Highlight your experience in quality assurance and clinical audits, and don’t forget to mention any relevant qualifications or certifications that align with the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality in clinical development and how your skills can contribute to our mission at CSL Seqirus. Keep it concise but impactful!
Showcase Your Communication Skills: Since this role involves working with various stakeholders, make sure to highlight your communication skills in your application. Share examples of how you've effectively collaborated with teams or managed negotiations in past roles.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way to ensure your application gets the attention it deserves, and you’ll find all the details you need right there!
How to prepare for a job interview at CSL Plasma
✨Know Your Regulations
Make sure you brush up on global 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 understand their implications for clinical trial integrity.
✨Audit Experience is Key
Prepare to share specific examples from your past audit experiences. Highlight how you identified non-compliance trends and what corrective actions you implemented. This will demonstrate your hands-on expertise and problem-solving skills.
✨Communication is Crucial
Since this role involves working with various stakeholders, practice articulating your thoughts clearly. Think of scenarios where you had to negotiate or collaborate with teams, and be ready to discuss how you navigated those situations.
✨Show Your Analytical Skills
Be prepared to discuss how you approach trend analysis and risk categorisation. Bring examples of how your analytical mindset has led to improvements in audit processes or compliance measures in your previous roles.