GCP Auditor

Blackfield Associates; England; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading biopharmaceutical company in the UK is seeking a Lead Quality Assurance Consultant. The successful candidate will be responsible for planning and executing GCP audits, managing clinical vendors, and ensuring inspection readiness. They should have a degree in a scientific discipline and significant experience in conducting international GCP audits. This role involves international travel and local travel to Stevenage. Competencies in data analytics and knowledge of GxPs are advantageous.

Qualifications

• Significant experience conducting international GCP audits or working as a regulatory inspector.
• Experience in vendor qualification and oversight.
• Proficiency in data analytics and knowledge of GxPs.

Responsibilities

• Plan, conduct, and report on international GCP audits.
• Manage clinical vendors, including onboarding and oversight.
• Maintain and review the risk-based audit plan.

Skills

GCP audits

Clinical vendor management

Data analytics

Regulatory inspection readiness

Education

Degree in life sciences, pharmacy or nursing

Recognized Clinical Research or Clinical Audit qualifications

Job description

Lead Quality Assurance Consultant - United Kingdom & Ireland

Blackfield is working with a leading biopharmaceutical company that is pioneering next‑generation T‑cell therapies for cancer and autoimmune diseases. This organization is committed to delivering life‑changing treatments and fostering a collaborative, inclusive, and development‑focused culture.

The successful candidate will plan, execute and manage a broad range of GCP‑focused audits including internal, investigator site and vendor audits. This role also includes clinical vendor qualification and lifecycle management, supporting regulatory inspection readiness, and contributing to CQA process improvements. International travel is required up to once per quarter, with local travel to Stevenage approximately once a month.

Key Responsibilities

• Plan, conduct, and report on international GCP audits, including internal, investigator site, and vendor audits.
• Manage and oversee clinical vendors, including qualification, onboarding, ongoing oversight, and offboarding.
• Maintain and review the risk‑based audit plan, track audit metrics, and report compliance risks.
• Support inspection readiness, regulatory inspections, and CQA process improvement initiatives.
• Ensure SOPs are current and aligned with best practices, escalating issues as needed.

Qualifications

We’re looking for a candidate with a degree in a scientific discipline (life sciences, pharmacy, nursing) or equivalent clinical research/QA experience, with significant experience conducting international GCP audits or working as a regulatory inspector. Experience in vendor qualification and oversight, along with recognized Clinical Research or Clinical Audit qualifications, is needed. A working knowledge of other GxPs such as GMP or GVP, proficiency in data analytics, and experience with GCLP/GVP audits would be advantageous.

Location & Travel

United Kingdom & Ireland. International travel required up to once per quarter, with local travel to Stevenage approximately once a month.

Contact

Please send your up‑to‑date CV to [e-mail] or call Oliver on 02392314792.

Biotechnology Research, Pharmaceutical Manufacturing, and Research Services