GCP Quality & Compliance Lead

Immunocore; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Immunocore seeks a Quality Manager- GCP to oversee QA activities within the QMS for clinical programs, ensuring GCP/GCLP/GVP compliance and regulatory readiness. This role collaborates across functions to manage CAPAs, audits, data integrity, and inspections in a fast-moving biotech environment.

The ideal candidate has 5+ years' QA experience in pharma/biotech, with strong knowledge of GxP and quality systems, and proven ability to influence stakeholders and drive improvements.

Qualifications

• Bachelor's degree required in a life sciences field with relevant experience.
• Minimum 5 years in Quality Assurance within pharma/biotech industries.
• Strong knowledge of ICH guidelines and regulatory expectations.
• Experience driving CAPAs and auditing supplier/vendor quality systems.

Responsibilities

• Perform internal and external audits for clinical activities per QA Audit Schedule.
• Oversee GCP and GVP activities impacting the QMS.
• Lead supplier/vendor audits to ensure GxP compliance and Immunocore standards.
• Prepare audit plans and report findings to senior stakeholders.
• Own and/or support QMS processes and risk assessments.
• Evaluate potential risks and ensure timely QA interventions.
• Support escalation and management of CAPAs, RCA, and quality issues.
• Assist in regulatory inspections planning and execution.
• Promote data integrity principles across GCP activities.
• Develop/update QA processes and SOPs for continuous improvement.
• Provide QA training and mentoring as required.
• Collaborate across functions to implement risk-based solutions.

Skills

GCP & GCLP knowledge

GxP compliance

QA processes & SOPs

CAPA/RCA & risk assessment

Interpersonal & cross-functional

Audit leadership

Data integrity awareness

Microsoft Office (MS Office)

Education

Bachelor's degree in life sciences or related field

Tools

Microsoft Office

Audit management tools

Job description

Immunocore seeks a Quality Manager- GCP to oversee QA activities within the QMS for clinical programs, ensuring GCP/GCLP/GVP compliance and regulatory readiness. This role collaborates across functions to manage CAPAs, audits, data integrity, and inspections in a fast-moving biotech environment.

The ideal candidate has 5+ years' QA experience in pharma/biotech, with strong knowledge of GxP and quality systems, and proven ability to influence stakeholders and drive improvements.