Manager, Quality Assurance GCP
Immunocore
12 hours ago
Remote friendly (Gaithersburg, MD)
United States
Clinical Research and Development
Quality Manager – GCP (Clinical QA)
Responsibilities:
- Support Quality Assurance activities for clinical functions under the QMS.
- Perform internal/external audits per the QA Audit Schedule.
- Oversee GCP/GVP-related activities impacting the QMS.
- Lead/participate in audits of suppliers/vendors for GxP and quality compliance.
- Create audit plans; report findings to auditees and QA leadership.
- Own or assist with agreed QMS processes; evaluate risks, standards, and quality principles.
- Coordinate cross-functionally to manage Quality Issues, CAPAs, Root Cause Analysis (RCA), and other ad hoc business issues.
- Support preparation for and management of regulatory authority inspections.
- Establish/maintain Data Integrity processes and communicate GCP data integrity principles.
- Maintain up-to-date knowledge of applicable legislation/regulatory guidelines (incl. ICH E6(R3)).
- Conduct in-depth reviews of clinical data and documentation.
- Lead/support QA SOPs and risk assessment tool development/revision; drive continuous improvement.
- Provide clinical QA training/mentoring; support quality issue reviews and risk-based solutions.
- Partner with functions to resolve quality issues and audit findings.
- Travel: 30%.
Other duties:
- Participate in QA/clinical operational meetings (audit status, CAPAs).
- Support quarterly QMS review metrics and weekly Quality Monitoring actions.
Supervisory responsibility: None.
Qualifications/Skills:
- Established GCP/QA professional.
- Excellent knowledge of GCP, GCLP, and GVP (GMP an advantage).
- Strong GxP/GQMS understanding for regulatory compliance.
- Experience using QMS metrics/KPIs/QTLs to assess risks.
- Knowledge of corporate governance and healthcare regulations/laws/standards.
- Strong collaboration and interpersonal skills; excellent written/oral communication.
- Experience in clinical research, biotechnology, or pharma; at least 5 years in Quality Assurance.
- Intermediate Microsoft Office skills (Word/Excel/PowerPoint/Outlook).
Preferred:
- Prior experience managing quality systems in pharma/biotech.
- Knowledge of GMP/GLP; clinical trial/drug development process knowledge.
Education:
- 5–10 years related experience; Bachelor’s degree or equivalent.
US Salary Range: $107,250–$178,750.
Responsibilities:
- Support Quality Assurance activities for clinical functions under the QMS.
- Perform internal/external audits per the QA Audit Schedule.
- Oversee GCP/GVP-related activities impacting the QMS.
- Lead/participate in audits of suppliers/vendors for GxP and quality compliance.
- Create audit plans; report findings to auditees and QA leadership.
- Own or assist with agreed QMS processes; evaluate risks, standards, and quality principles.
- Coordinate cross-functionally to manage Quality Issues, CAPAs, Root Cause Analysis (RCA), and other ad hoc business issues.
- Support preparation for and management of regulatory authority inspections.
- Establish/maintain Data Integrity processes and communicate GCP data integrity principles.
- Maintain up-to-date knowledge of applicable legislation/regulatory guidelines (incl. ICH E6(R3)).
- Conduct in-depth reviews of clinical data and documentation.
- Lead/support QA SOPs and risk assessment tool development/revision; drive continuous improvement.
- Provide clinical QA training/mentoring; support quality issue reviews and risk-based solutions.
- Partner with functions to resolve quality issues and audit findings.
- Travel: 30%.
Other duties:
- Participate in QA/clinical operational meetings (audit status, CAPAs).
- Support quarterly QMS review metrics and weekly Quality Monitoring actions.
Supervisory responsibility: None.
Qualifications/Skills:
- Established GCP/QA professional.
- Excellent knowledge of GCP, GCLP, and GVP (GMP an advantage).
- Strong GxP/GQMS understanding for regulatory compliance.
- Experience using QMS metrics/KPIs/QTLs to assess risks.
- Knowledge of corporate governance and healthcare regulations/laws/standards.
- Strong collaboration and interpersonal skills; excellent written/oral communication.
- Experience in clinical research, biotechnology, or pharma; at least 5 years in Quality Assurance.
- Intermediate Microsoft Office skills (Word/Excel/PowerPoint/Outlook).
Preferred:
- Prior experience managing quality systems in pharma/biotech.
- Knowledge of GMP/GLP; clinical trial/drug development process knowledge.
Education:
- 5–10 years related experience; Bachelor’s degree or equivalent.
US Salary Range: $107,250–$178,750.