Quality Manager GCP

Role Summary

The Quality Manager - GCP will oversee QA activities within the company, focusing on the Quality Management System (QMS) and ensuring GCP/GxP compliance for clinical activities. You will work cross-functionally to develop systems and processes in-line with regulatory requirements, GCP, GCLP, GVP and internal quality standards. The role includes supporting internal, external, and supplier audits, managing Quality Issues, CAPAs, Root Cause Analysis, and facilitating regulatory inspections. The position requires collaboration in a fast-paced, innovative environment and travel up to 30%. Location: US - 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 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%

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 Experience & Knowledge

• 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