We are looking for an excellent Quality Manager to provide support for CMC Department within the company. Overseeing the Quality Management System for CMC and working closely with internal colleagues to develop systems and processes in line with related regulatory requirements, GMP and internal quality processes.
Key Responsibilities are:
- Overseeing the Quality Management System for CMC. Review processes and summarise in process maps. Establishing processes to ensure data integrity and communicating the principles of data integrity.
- Assist in managing the core QMS and QA processes including being Process Owner for some agreed core QMS Processes.
- Performing internal system audits for CMC as defined in Internal Audit Schedule. Prepare audit plans, perform and reporting audit findings to the auditee, Head of Functional area and Head of QA.
- Assist in other internal audits, as required.
- Leading audits of third party providers for CMC (excluding those requiring a QP) as per Supplier Audit Schedule and assist/support other Supplier Audits.
- Maintaining an up to date knowledge and log of applicable legislation and regulatory guidelines. Understand and interpret the regulatory expectations and provide guidance on their implementation.
- Provide in-depth quality reviews of data and documentation, as required.
- Assisting with the smooth running of the regulated CMC facilities. Providing guidance on the following:
- Non-conformances and Quality Events
- Change Control
- Supplier Assessment and Management
- Root Cause Analysis and CAPA
- Complaints and Product Recall
- Provide training/mentoring on any aspect of Quality as required.
- Contribution to the scientific, intellectual property, and business development aspects of the company’s activities in order to grow its value.
Skills & Experience:
- Excellent understand of quality management systems and “good practices” (GxP), to ensure compliance with regulatory requirements
- Excellent knowledge of GMP (GCP and GLP an advantage)
- Previous experience of working in Clinical Research or the Pharmaceutical Industry
- Knowledge of the Industry manufacturing process and drug development
- Knowledge of the manufacture of sterile injectable T cell antigen receptor-based therapeutics produced in bacterial cell culture.
- Work collaboratively with existing teams
- Able to foster support and influence all stakeholders throughout the company
- Extensive experience within Quality Assurance in a similar industry
- Excellent proven auditing, written and oral communication skills.
- Worked with Microsoft Office at an intermediate level (i.e. Word, Excel, PowerPoint Outlook)
- Previous experience of managing quality systems in the pharmaceutical or Biotech industry
- Knowledge of GCP and GLP
- Knowledge of the Industry/Clinical trial process and drug development
We look forward to hearing from you !