Auditor - GCP
Added 1 Sept · still live
Not disclosed
Salary
Not disclosed by employer
£48,200
Going rate
Skilled Worker going rate
This role likely qualifies for a Skilled Worker visa
SOC 2482 (92% match) is an eligible occupation, with a going rate of £48,200, and CSL is a licensed sponsor. That is our reading of the rules. Whether they issue a Certificate of Sponsorship is still their call.
About the role
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
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: 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.
This description is the source posting as it read when we added it. We are not affiliated with CSL, so check their own site for the current details.
Where this offer sits in the market
SOC 2482 · UK · ONS ASHE 2025 · ~137k in sampleP25 £40kP75 £66k
£33kmedian £50kgoing rate £48k£84k
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Does this job guarantee visa sponsorship?
Not necessarily. CSL holds a sponsor licence, but sponsorship for a specific hire is always the employer's decision. Be upfront in your application that you'll require it.
What salary is needed for this role to be eligible?
The offer must clear both the general threshold and the SOC 2482 going rate of £48,200. New-entrant and shortage discounts can lower it.