At a Glance
- Tasks: Conduct audits to ensure compliance and accuracy in clinical trials.
- Company: Join CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Enjoy competitive benefits, including health support and a focus on well-being.
- Other info: Dynamic role with opportunities for travel and professional growth.
- Why this job: Make a real impact in clinical research while working with innovative therapies.
- Qualifications: 3+ years in Quality Assurance within GCP environments; strong communication skills required.
The predicted salary is between 36900 - 45100 £ per year.
Quality in clinical development is a matter of operational resilience as much as regulatory mandate. This role serves as a GCP 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: 3+ years of 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.
- Working Knowledge of: ICH E6 (R3) Guideline, 21 CFR Part 11 – Electronic Records; Electronic Signatures, 21 CFR Part 50 – Protection of Human Subjects (Informed Consent), 21 CFR Part 312 – Investigational New Drug Application, 21 CFR Part 812 – Investigational Device Exemptions, Clinical Trials Regulation (CTR) (EU) No 536/2014, Directive 2001/20/EC (Clinical Trial Directive), Directive 2005/28/EC (GCP Directive), Directive 2001/83/EC (Annex I).
- 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% travel.
Auditor - GCP in Maidenhead employer: CSL Behring UK
CSL Behring is an exceptional employer that prioritises employee well-being and professional growth within a dynamic and inclusive work culture. With a commitment to innovation in biotherapeutics, employees benefit from comprehensive training opportunities, a supportive environment for collaboration, and the chance to make a meaningful impact on patients' lives globally. Located in a vibrant area, CSL Behring offers a unique opportunity to be part of a leading organisation dedicated to saving lives while fostering a diverse and engaged workforce.
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We think this is how you could land Auditor - GCP in Maidenhead
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We think you need these skills to ace Auditor - GCP in Maidenhead
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at CSL Behring UK!
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How to prepare for a job interview at CSL Behring UK
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at CSL Behring UK that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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