Manager, Quality Assurance GCP
Immunocore
2 hours ago
Remote friendly (Gaithersburg, MD)
United States
Clinical Research and Development
Quality Manager – GCP (Clinical QA)
Responsibilities
- Perform internal and external audits for clinical activities per the QA Audit Schedule.
- Support management and oversight of GCP and GVP-related activities impacting the QMS.
- Lead or participate in audits of suppliers/vendors to assess compliance with GxP requirements and Immunocore quality standards.
- Prepare audit plans and report audit findings to the auditee, Head of Functional area, and Head of QA.
- Assist in managing core clinical and QA processes; own certain agreed QMS processes (as applicable).
- Evaluate and provide oversight for risks, standards, and quality principles.
- Work cross-functionally to support escalation and management of Quality Issues, CAPAs, Root Cause Analysis (RCA), and ad hoc business process issues.
- Support regulatory inspection preparation and management.
- Establish and support Data Integrity processes for GCP.
- Maintain up-to-date knowledge of applicable legislation and regulatory guidelines, including ICH E6 (R3).
- Conduct in-depth quality reviews of data and documentation.
- Lead/support development and/or revision of QA processes/procedures, including SOPs and risk assessment tools; drive continuous improvements.
- Provide training/mentoring on clinical QA.
- Support timely, risk-based implementation of solutions for quality issues.
- Travel ~30%.
- Participate in QA/clinical operational meetings; review QMS metrics quarterly; contribute to weekly quality monitoring action items.
Qualifications (Essential)
- Established GCP/QA professional.
- Excellent knowledge of GCP, GCLP, and GPvP (GMP an advantage).
- Strong understanding of quality management systems and GxP to ensure regulatory compliance.
- Experience using QMS metrics, KPIs, and QTLs to assess risks to clinical research/drug development.
- Knowledge of corporate governance, healthcare regulations, laws, and standards.
- Strong collaboration, partnering, and interpersonal skills.
- Experience in clinical research, biotechnology, or pharmaceuticals.
- Excellent analytical, written, and oral communication skills; able to influence stakeholders.
- Intermediate Microsoft Office skills.
- At least 5 years working in Quality Assurance in a similar industry.
Preferred
- Experience managing quality systems in pharma/biotech.
- Knowledge of GMP/GLP (GLP an advantage).
- Knowledge of clinical trial processes and drug development.
Education
- 5–10 years related experience in pharmaceutical and/or biotech industry.
- Bachelor’s degree or equivalent combination of education and experience.
Compensation
- US salary range: $107,250–$178,750.
Responsibilities
- Perform internal and external audits for clinical activities per the QA Audit Schedule.
- Support management and oversight of GCP and GVP-related activities impacting the QMS.
- Lead or participate in audits of suppliers/vendors to assess compliance with GxP requirements and Immunocore quality standards.
- Prepare audit plans and report audit findings to the auditee, Head of Functional area, and Head of QA.
- Assist in managing core clinical and QA processes; own certain agreed QMS processes (as applicable).
- Evaluate and provide oversight for risks, standards, and quality principles.
- Work cross-functionally to support escalation and management of Quality Issues, CAPAs, Root Cause Analysis (RCA), and ad hoc business process issues.
- Support regulatory inspection preparation and management.
- Establish and support Data Integrity processes for GCP.
- Maintain up-to-date knowledge of applicable legislation and regulatory guidelines, including ICH E6 (R3).
- Conduct in-depth quality reviews of data and documentation.
- Lead/support development and/or revision of QA processes/procedures, including SOPs and risk assessment tools; drive continuous improvements.
- Provide training/mentoring on clinical QA.
- Support timely, risk-based implementation of solutions for quality issues.
- Travel ~30%.
- Participate in QA/clinical operational meetings; review QMS metrics quarterly; contribute to weekly quality monitoring action items.
Qualifications (Essential)
- Established GCP/QA professional.
- Excellent knowledge of GCP, GCLP, and GPvP (GMP an advantage).
- Strong understanding of quality management systems and GxP to ensure regulatory compliance.
- Experience using QMS metrics, KPIs, and QTLs to assess risks to clinical research/drug development.
- Knowledge of corporate governance, healthcare regulations, laws, and standards.
- Strong collaboration, partnering, and interpersonal skills.
- Experience in clinical research, biotechnology, or pharmaceuticals.
- Excellent analytical, written, and oral communication skills; able to influence stakeholders.
- Intermediate Microsoft Office skills.
- At least 5 years working in Quality Assurance in a similar industry.
Preferred
- Experience managing quality systems in pharma/biotech.
- Knowledge of GMP/GLP (GLP an advantage).
- Knowledge of clinical trial processes and drug development.
Education
- 5–10 years related experience in pharmaceutical and/or biotech industry.
- Bachelor’s degree or equivalent combination of education and experience.
Compensation
- US salary range: $107,250–$178,750.