Job description

Quality Assurance (QA) Manager- CMC

91 Park Drive, Milton Park, Oxfordshire, OX14 4RY, UK

Quality Assurance (QA) Manager- CMC

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

 

The role

Responsibilities:

  • Oversight of the Quality Management System for CMC. Review processes and summarise in process maps. Establishing processes to ensure data integrity compliance and communicating the principles of data integrity.
  • Assist in managing the core QMS including being Process Owner for some agreed core QMS components.
  • Provide QA oversight and support for GMP QC laboratories and associated processes.
  • Conduct internal audits for CMC functions as defined in the Internal Audit Schedule.
  • Lead vendor audits of third-party service providers for CMC (excluding those requiring a QP) as per the Vendor Audit Schedule.
  • Assist as support auditor and with audit coordination activities for internal and vendor audits, as required.
  • Maintain 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.
  • Assist with the smooth running of the regulated CMC facilities. Providing guidance on the following:
    • Quality Issue.
    • Change Control.
    • Vendor 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.

Qualifications: 

  • Excellent understand of quality management systems and good practices, to ensure compliance with regulatory requirements.
  • Excellent knowledge of CMC requirements, GMP and GDP (GCP and GLP advantageous).
  • 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.
  • Experience with Microsoft Office applications at an intermediate level (i.e. Word, Excel, PowerPoint Outlook).

Education:

  • A degree or higher degree in a relevant scientific subject (biologically based)

Lead with Science and Discover What is Within:

  • We Value Entrepreneurship and Diversity
  • Respect, Trust, and Integrity
  • Competitive compensation
  • Private medical and dental benefits.
  • 25 days Annual Leave and Bank Holidays
  • 4x Salary Life Insurance
  • 5% Pension Match
  • Income Protection
  • Parental Leave

 

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