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: Dynamic role with up to 50% global travel and strong career advancement potential.
- Why this job: Make a real impact on clinical research integrity and patient safety.
- Qualifications: BS degree in biological science and quality assurance experience in 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 employer: CSL Seqirus
CSL Seqirus is an exceptional employer that prioritises quality and innovation in clinical development, offering a collaborative work culture where employees can thrive. With a strong commitment to inclusion and belonging, the company provides ample opportunities for professional growth and development, alongside competitive benefits that support employee well-being. Located in a dynamic environment, CSL Seqirus empowers its workforce to make a meaningful impact on global health through their contributions to influenza vaccine production.
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 all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. We want you to walk into that interview feeling confident and ready to show them why you’re the perfect fit for the Auditor role.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to quality assurance and clinical trials. We suggest doing mock interviews with friends or mentors to get comfortable with articulating your experience and skills.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email can go a long way in showing your appreciation and keeping you top of mind. And remember, apply through our website for the best chance at landing that role!
We think you need these skills to ace Auditor - CQA
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the Auditor role. Highlight your quality assurance experience and any relevant audit expertise to show us you’re the right fit!
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 background aligns with our mission at CSL Seqirus.
Showcase Your Communication Skills:Since this role involves working with various stakeholders, emphasise your interpersonal and negotiation skills in your application. We want to see how you can effectively collaborate in a multinational environment!
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 ensure you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at CSL Seqirus
✨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.
✨Showcase Your Audit Experience
Prepare 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.
✨Communicate Effectively
Practice articulating your thoughts clearly and confidently. Since this role involves working with multinational teams and stakeholders, showcasing your excellent interpersonal skills during the interview is crucial.
✨Be Ready for Scenario Questions
Expect scenario-based questions where you might need to navigate complex clinical environments. Think about how you would approach various audit situations and be prepared to discuss your thought process and decision-making.
