Quality Manager GCP

Role Summary

Quality Manager – GCP responsible for QA activities supporting clinical programs, overseeing the Quality Management System (QMS), and ensuring compliance with regulatory requirements including GCP, GCLP, and GVP. Collaborates cross-functionally to manage Quality Issues, CAPAs, RCA, and data integrity. Location: US Gaithersburg, MD or Radnor, PA. Travel up to 30%.

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, CAPAs, RCA, and 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.

Qualifications

• Essential: 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 (Word, Excel, PowerPoint, Outlook).
• Worked within Quality Assurance in a similar industry for at least 5 years.

Preferred Experience & Knowledge

• 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.

Education

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