Quality Manager GCP

Location of role US
- Gaithersburg, MD or Radnor, PA

Department Clinical QA

The Quality Manager- GCP role will support the execution of Quality Assurance activities within the company, overseeing clinical activities relating to the Quality Management System (QMS), and working closely with internal colleagues to develop systems and processes in-line with regulatory requirements, GCP and internal quality processes, as applicable.

This role will also support GCP internal, external, and supplier audits in accordance with international GCP requirements and Immunocore standards, The Quality Manager (GCP) is responsible for working 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.

The ideal candidate will leverage his/her experience, understanding of GCP, GCLP, GVP and interpersonal skills, to proactively contribute to QA oversight activities leading to QMS, GCP, GCLP, GVP and regulatory compliance. This role will also require someone who can work within a highly innovative, agile and entrepreneurial environment and is able to effectively collaborate while working under pressure to achieve timelines and ensure compliance with QMS and regulatory requirements.

• 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.

• 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.

This position has no supervisory responsibilities

• 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…