Clinical Compliance/Inspection Readiness, Manager - Clinical Operations
Immunocore
August 23, 2026
On-site
Radnor, PA
Operations
Key Responsibilities:
- Manage inspection preparedness and provide inspection support for clinical quality compliance.
- Lead development and delivery of GCP and Inspection Readiness training for the Clinical organization.
- Develop and implement processes/tools to help teams be inspection ready.
- Provide ongoing inspection readiness support, including risk mitigation and monitoring.
- Prepare for audits and regulatory agency inspections (including ongoing storyboarding).
- Represent Clinical Compliance in Sponsor audits and Regulatory Agency inspections; supervise Clinical preparation room activities.
- Coordinate follow-up on audits/inspections, responses, commitments, post-inspection activities, and CAPA.
- Generate, analyze, and communicate inspection readiness metrics and compliance/inspection readiness KPIs.
- Drive continuous improvement in inspection readiness and inspection conduct support.
- Lead development/approval of controlled documents (Policies, SOPs, Work Instructions, forms/templates) compliant with global regulatory standards.
- Execute role-based curriculum and GCP training strategy.
- Collaborate with QA to prepare/collect training documents for internal training file audit.
- Support compliance assessments (e.g., vendor/contractor qualification) with QA.
- Assist with oversight/tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI) and ensure follow-up.
- Support internal audit reports; identify process improvement/training needs.
- Track open Quality Issues and CAPAs; coordinate timely closure with Clinical stakeholders.
Other Duties:
- Support internal/external clinical operations teams for audits.
- Train on Clinical SOPs and Work Instructions.
- Support/manage clinical quality database observations with QA.
- Lead continuous improvement of good clinical practices; manage budgets/schedules/work plans for inspection readiness support.
- Communicate with senior management/executives.
Essential Qualifications/Skills:
- 8+ years in biotech/pharma and/or CRO with experience in compliance, quality, training, or clinical operations.
- Expertise in global clinical research regulatory/compliance requirements (US CFR, EU CTD, ICH GCP).
- Experience performing PAI and inspection readiness assessments.
- Ability to make high-level presentations (oral/written).
- Demonstrated ownership, flexibility, effective collaboration, and meeting project timelines.
Desirable:
- Clinical auditing; compliance and training experience.
Education:
- BA/BS or higher in a science-related field.
- 8+ years relevant experience; some QA/Audit setting preferred.
- Clinical Operations and/or Inspection Readiness experience preferred.
- Proficient with Microsoft tools (Word, Excel, PowerPoint, Outlook, MS Project, SharePoint).
Travel:
- Up to ~20% local/international travel.
- Manage inspection preparedness and provide inspection support for clinical quality compliance.
- Lead development and delivery of GCP and Inspection Readiness training for the Clinical organization.
- Develop and implement processes/tools to help teams be inspection ready.
- Provide ongoing inspection readiness support, including risk mitigation and monitoring.
- Prepare for audits and regulatory agency inspections (including ongoing storyboarding).
- Represent Clinical Compliance in Sponsor audits and Regulatory Agency inspections; supervise Clinical preparation room activities.
- Coordinate follow-up on audits/inspections, responses, commitments, post-inspection activities, and CAPA.
- Generate, analyze, and communicate inspection readiness metrics and compliance/inspection readiness KPIs.
- Drive continuous improvement in inspection readiness and inspection conduct support.
- Lead development/approval of controlled documents (Policies, SOPs, Work Instructions, forms/templates) compliant with global regulatory standards.
- Execute role-based curriculum and GCP training strategy.
- Collaborate with QA to prepare/collect training documents for internal training file audit.
- Support compliance assessments (e.g., vendor/contractor qualification) with QA.
- Assist with oversight/tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI) and ensure follow-up.
- Support internal audit reports; identify process improvement/training needs.
- Track open Quality Issues and CAPAs; coordinate timely closure with Clinical stakeholders.
Other Duties:
- Support internal/external clinical operations teams for audits.
- Train on Clinical SOPs and Work Instructions.
- Support/manage clinical quality database observations with QA.
- Lead continuous improvement of good clinical practices; manage budgets/schedules/work plans for inspection readiness support.
- Communicate with senior management/executives.
Essential Qualifications/Skills:
- 8+ years in biotech/pharma and/or CRO with experience in compliance, quality, training, or clinical operations.
- Expertise in global clinical research regulatory/compliance requirements (US CFR, EU CTD, ICH GCP).
- Experience performing PAI and inspection readiness assessments.
- Ability to make high-level presentations (oral/written).
- Demonstrated ownership, flexibility, effective collaboration, and meeting project timelines.
Desirable:
- Clinical auditing; compliance and training experience.
Education:
- BA/BS or higher in a science-related field.
- 8+ years relevant experience; some QA/Audit setting preferred.
- Clinical Operations and/or Inspection Readiness experience preferred.
- Proficient with Microsoft tools (Word, Excel, PowerPoint, Outlook, MS Project, SharePoint).
Travel:
- Up to ~20% local/international travel.