Clinical Compliance & Inspection Readiness Lead

BioSpace; Radnor (Delaware County); On-site; USD 107,000 - 179,000; Full time

Job summary

Immunocore, a pioneering biopharma company, is seeking a Clinical Compliance/Inspection Readiness Manager to lead training and readiness activities across Gaithersburg, MD and Conshohocken, PA. This onsite role supports GMP-like regulatory standards and coordinates audit readiness across clinical operations.

You will develop processes, oversee CAPA and inspection responses, and drive role-based curricula to ensure readiness for sponsor and regulatory inspections, while partnering with QA and

Qualifications

• 8+ years in biotech/pharma with compliance, quality, training or clinical ops.
• Experience with US CFR, EU CTD, ICH GCP regulatory standards.
• Evidence of training program development and delivery.

Responsibilities

• Lead development and delivery of GCP and Inspection Readiness training at Gaithersburg or Conshohocken sites.
• Develop processes and tools to support teams for inspection readiness.
• Provide ongoing inspection readiness support to study teams, including CAPA tracking.

Skills

Regulatory compliance

GCP training

Audit readiness

Presentation skills

Education

BA/BS in science

Tools

Microsoft Office

Job description

Immunocore, a pioneering biopharma company, is seeking a Clinical Compliance/Inspection Readiness Manager to lead training and readiness activities across Gaithersburg, MD and Conshohocken, PA. This onsite role supports GMP-like regulatory standards and coordinates audit readiness across clinical operations.

You will develop processes, oversee CAPA and inspection responses, and drive role-based curricula to ensure readiness for sponsor and regulatory inspections, while partnering with QA and