QA Manager, GCP & Compliance Audits (Remote)

BioSpace; Gaithersburg (MD); Remote; USD 125,000 - 150,000; Full time

Job summary

Immunocore is seeking a Manager of Quality Assurance GCP to lead audits and oversee GxP compliance across global clinical activities. This role requires deep expertise in GCP, GCLP and GPvP, with strong QMS governance and risk management capabilities.

The role covers audits of suppliers, data integrity, regulatory inspections, and continuous improvement of QA processes within a biotech environment. Travel up to 30% is expected as part of responsibilities.

Qualifications

• Established GCP / QA professional.
• Excellent knowledge of GCP, GCLP, GPvP.
• Strong understanding of quality management systems (GxP) to ensure compliance with regulatory requirements.
• Experience utilizing QMS metrics, KPIs, and QTLs to assess risks to clinical research and drug development processes.

Responsibilities

• Perform audits for clinical activities per QA Audit Schedule.
• Support management of GCP and GVP related activities impacting the QMS.
• Lead or participate in supplier audits to ensure GxP compliance.
• Prepare audit plans and report findings to leaders.
• Assist in managing core clinical QA processes and risk assessment.

Skills

GCP / QA

GxP knowledge

QMS metrics

Analytical skills

MS Office

Communication skills

Clinical research experience

Education

Bachelor’s degree or equivalent

Job description

Immunocore is seeking a Manager of Quality Assurance GCP to lead audits and oversee GxP compliance across global clinical activities. This role requires deep expertise in GCP, GCLP and GPvP, with strong QMS governance and risk management capabilities.

The role covers audits of suppliers, data integrity, regulatory inspections, and continuous improvement of QA processes within a biotech environment. Travel up to 30% is expected as part of responsibilities.