At a Glance
- Tasks: Conduct audits to ensure compliance and accuracy in clinical trials.
- Company: Join CSL Seqirus, a leading global influenza vaccine provider.
- Benefits: Enjoy competitive benefits, including travel opportunities and professional growth.
- Other info: Be part of a diverse team that values inclusion and innovation.
- Why this job: Make a real impact on clinical research integrity and patient safety.
- Qualifications: BS degree in biological science and experience in quality assurance.
The predicted salary is between 45000 - 55000 € 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.
- 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 employer: CSL Plasma Inc.
CSL Seqirus is an exceptional employer that prioritises operational resilience and regulatory compliance in clinical development. With a strong commitment to inclusion and belonging, employees benefit from a collaborative work culture that fosters innovation and personal growth. The role of CQA Auditor offers unique opportunities for professional development through global travel and engagement with diverse teams, all while contributing to the vital mission of preventing influenza worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Auditor - CQA
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We can’t stress enough how personal connections can open doors that applications alone can’t.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your skills as an auditor. We want you to walk in confident, ready to showcase how you can contribute to their mission.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to audit execution and compliance. We recommend doing mock interviews with friends or mentors to refine your answers and get comfortable with the process.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can leave a lasting impression. We believe it shows your enthusiasm for the role and keeps you on their radar as they make their decision.
We think you need these skills to ace Auditor - CQA
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your relevant experience in quality assurance and clinical audits. We want to see how your background aligns with the responsibilities of the CQA Auditor role, so don’t be shy about showcasing your skills!
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 experience can contribute to our mission at CSL Seqirus. Keep it engaging and personal!
Showcase Your Regulatory Knowledge:Since this role requires up-to-date knowledge of GCP regulations, make sure to mention any relevant certifications or training you've completed. We love seeing candidates who are proactive about staying informed in the field!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to track your application status. Plus, we love seeing applications come in through our official channels!
How to prepare for a job interview at CSL Plasma Inc.
✨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 can also apply them in real-world scenarios.
✨Audit Experience is Key
Prepare specific examples from your past audit experiences. Be ready to discuss how you identified non-compliance trends and what corrective actions you implemented. This will demonstrate your hands-on expertise in clinical audits.
✨Communication Skills Matter
Since this role involves working with various stakeholders, practice articulating your thoughts clearly. Think of examples where your communication skills helped resolve issues or improved collaboration within a team.
✨Show Your Analytical Side
Be prepared to discuss how you approach problem-solving and trend analysis. Share instances where your analytical skills led to significant improvements in audit processes or compliance standards.
