Inspection-Ready Clinical Compliance Lead

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

Job summary

Immunocore is seeking a Clinical Compliance/Inspection Readiness Manager to lead inspection preparedness, support for audits, and development of clinical procedures. The role focuses on training, process improvement, and cross-functional collaboration across Gaithersburg, MD or Conshohocken, PA sites.

Requires 8+ years in biotech/pharma with regulatory and QA experience; knowledge of US CFR, EU GCP, and ICH; strong leadership and communication skills. Limited travel may be required.

Qualifications

• At least 8 years in biotech/pharma with compliance, quality, training or related clinical operations.
• Expertise in global regulatory requirements for clinical research, including US CFR, EU GCP and ICH.
• Ability to lead and train teams; strong written and verbal communication.

Responsibilities

• Lead development and delivery of GCP and inspection-readiness training for Clinical organization.
• Develop processes and tools to support teams to stay inspection-ready.
• Provide inspection-readiness support to study teams with risk mitigation and monitoring.
• Coordinate audits and regulatory inspections, including storyboarding and CAPA follow-up.
• Represent Clinical Compliance in sponsor audits and inspections; supervise preparation activities.

Skills

Inspection readiness

GCP training

Quality systems

Risk assessment

Regulatory compliance

Education

BA/BS in science

Tools

Microsoft Office

Job description

Immunocore is seeking a Clinical Compliance/Inspection Readiness Manager to lead inspection preparedness, support for audits, and development of clinical procedures. The role focuses on training, process improvement, and cross-functional collaboration across Gaithersburg, MD or Conshohocken, PA sites.

Requires 8+ years in biotech/pharma with regulatory and QA experience; knowledge of US CFR, EU GCP, and ICH; strong leadership and communication skills. Limited travel may be required.