Immunocore · 8 hours ago
Quality Manager GCP
Radnor, PA
Full-time
Onsite
Senior Level
5+ years expImmunocore is a pioneering biotechnology company focused on developing transformative medicines. The Quality Manager - GCP role involves overseeing Quality Assurance activities related to clinical activities and ensuring compliance with regulatory requirements, GCP, and internal quality processes.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Perform internal and external audits for clinical activities as defined by the QA Audit Schedule
Support the management and oversight of GCP and GVP related activities impacting the QMS
Lead or participate in audits of suppliers/vendors to evaluate processes, systems and procedures for compliance to GxP requirements and Immunocore Quality standards
Prepare audit plans, perform and report audit findings to the auditee, Head of Functional area and Head of QA
Assist in managing core clinical and QA processes including being owner for some agreed QMS processes, as applicable
Evaluate and provide oversight for potential risks, standards and quality principles
Work cross-functionally with stakeholders across the business to support the escalation and management of Quality Issues, Corrective and Preventative Actions (CAPAs), Root Cause Analysis (RCA), as well as ad hoc issues impacting business processes
Support Inspection Management Team in preparation for and management of regulatory authority inspections
Assist in establishing processes to ensure Data Integrity and communicate the principles of data integrity for GCP
Maintain an up-to-date knowledge and log of applicable legislation and regulatory guidelines, including ICH E6 (R3) guidelines
Provide in-depth quality reviews of data and documentation, as required
Lead or support the development and/or revision of QA processes and procedures including SOPs and risk assessment tools, continuous improvements
Provide training/mentoring on clinical QA as required
Support the review of quality issues and collaborate cross-functionally to ensure risk-based solutions are implemented in a timely manner
Partnering with functions to find solutions for Quality Issues and audit findings
Travel 30%
Participate QA and clinical operational meetings to discuss the status of audits, planned audits, and outstanding CAPAs
Support the review of metrics as part of quarterly QMS review meeting
Attend and contribute to action items identified as part of weekly Quality Monitoring meetings
Qualification
Required
Established GCP / QA professional
Excellent knowledge of GCP, GCLP, GPvP (GMP an advantage)
Strong understanding of quality management systems and (GxP), to ensure compliance with regulatory requirements
Experience utilizing QMS metrics, KPIs, and QTLs to assess risks to clinical research and drug development processes
Knowledge of corporate governance, health care regulations, laws and standards
Strong collaborative, partnering, and interpersonal skills
Previous experience working in clinical research, biotechnology or the pharmaceutical industry
Excellent analytical, written and oral communications skills
Able to foster support and influence all stakeholders throughout the company
Worked with Microsoft Office at an intermediate level (i.e. Word, Excel, PowerPoint Outlook)
Worked within Quality Assurance in a similar industry for at least 5 years
BS with at least 5-10 years' experience within pharmaceutical and/or biotech industry
Preferred
Previous experience of managing quality systems in the pharmaceutical or biotechnology industry
Knowledge of GMP, GLP an advantage
Knowledge of the industry/clinical trial process and drug development
Company
Immunocore
Immunocore is a biotechnology company that specializes in the development of TCR bispecific immunotherapies.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.16BKey Investors
BlackRockOxford Finance LLCGeneral Atlantic
2024-01-30Post Ipo Debt· $350M
2022-07-18Post Ipo Equity· $140M
2021-02-04IPO
Leadership Team
Bahija Jallal
Chief Executive Officer
Tina St. Leger
Chief Human Resources Officer
Recent News
2025-11-29
2025-11-11
Company data provided by crunchbase