Quality Manager GCP

Role Summary

Quality Manager, GCP will support QA activities for clinical GxP compliance, overseeing the Quality Management System (QMS), and collaborating with internal teams to develop processes in line with regulatory requirements, GCP, GCLP, GVP, and Immunocore standards. The role includes coordinating internal, external, and supplier audits, and driving CAPAs and RCA to resolve quality issues. The successful candidate will contribute to QA oversight to ensure QMS and regulatory compliance in a fast-paced, entrepreneurial environment. Location: US-based (Conshohocken, PA or Gaithersburg, MD).

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 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.
• Partner with functions to find solutions for Quality Issues and audit findings.
• 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 meetings.
• Attend and contribute to action items identified as part of weekly Quality Monitoring meetings.

Qualifications

• Required: Established GCP / QA professional.
• Required: Excellent knowledge of GCP, GCLP, GPvP (GMP an advantage).
• Required: Strong understanding of quality management systems and (GxP), to ensure compliance with regulatory requirements.
• Required: Experience utilizing QMS metrics, KPIs, and QTLs to assess risks to clinical research and drug development processes.
• Required: Knowledge of corporate governance, health care regulations, laws and standards.
• Required: Strong collaborative, partnering, and interpersonal skills.
• Required: Previous experience working in clinical research, biotechnology or the pharmaceutical industry.
• Required: Excellent analytical, written and oral communications skills.
• Required: Able to foster support and influence all stakeholders throughout the company.
• Required: Worked with Microsoft Office at an intermediate level (i.e. Word, Excel, PowerPoint Outlook).
• Required: Worked within Quality Assurance in a similar industry for at least 5 years.
• Preferred: Previous experience of managing quality systems in the pharmaceutical or biotechnology industry.
• Preferred: Knowledge of GMP, GLP an advantage.
• Preferred: Knowledge of the industry/clinical trial process and drug development.

Education

• BS with at least 5-10 years’ experience within pharmaceutical and/or biotech industry

Additional Requirements

• Travel: Up to 30% travel