Current Vacancies

Head of Quality Assurance

OVERALL ROLE OJBECTIVE

TC BioPharm (TCB) is looking to recruit a Head of Quality Assurance to join the management team. This is an exciting opportunity to join an emerging cancer immunotherapy company developing cell based treatments in a senior management role.

You will provide leadership and direction to an integrated quality assurance function and as an integral member of the site management team, you will be responsible for ensuring that the quality assurance aspects of the company on site are being conducted according to all internal and external quality and regulatory compliance requirements. A proven track record in a similar role within a biologics / life sciences environment is an essential requirement for this role.

Aligned to the business, this role is as diverse as it is essential, and this challenging opportunity requires you to adopt a hands-on operational approach, and at the same time influence strategic decisions together with coordinating wide-ranging process improvement projects.

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

  • Lead and manage the strategic and operational performance of the Quality Assurance function ensuring the successful delivery of business strategy, key performance indicators (KPIs) and objectives, whilst adhering to regulatory compliance and achieving commercial success. Work closely with the GMP Production team and Quality Control team to ensure that GMP cell therapy products are manufactured in a consistent and reproducible manner, working with the clinical team to ensure patients are treated as scheduled.
  • To manage and assist in the development of structures, policies, processes & procedures to ensure effective and accountable use of resources across the Quality assurance function.
  • To manage and ensure that the quality management systems, processes and procedures are implemented across the manufacturing facilities to ensure that product released is fit for use and is compliant with appropriate regulatory commitments.
  • Provide leadership, direction & development to the QA team.
  • To represent the company to authorities and service providers on all quality assurance matters.
  • Contribute to the site performance as agreed through the performance management objectives on the basis of informed advice on quality requirements.
  • Assist the Head of Quality in the development, collating and reporting of key quality and business metrics to drive a culture of continuous process improvement such that it is fully compliant with current EU/FDA regulations and quality requirements.
  • Ensure that systems and processes for the management of complaints and product recalls are being conducted in accordance with the licensed risk management systems.
  • To advise on compliance requirements and strategies for process development and technology transfer activities.
  • Laisse with the QP where appropriate in the planning, co-ordination, interpretation and compilation of relevant information necessary for regulatory submission to ensure successful granting, maintenance and variations of licences.
  • Responsible for coordination & preparation of regulatory submissions and strategies.
  • Develop & maintain regulatory knowledge of EU/FDA regulations and potentially other territories.

QUALIFICATIONS

  • Be educated to degree level in a sciences discipline.

SKILLS & EXPERIENCE

  • Be results focused, commercially aware and driven, with a proven track record in leading a Quality Assurance team within a biologics manufacturing environment with relevant experience in Quality Assurance and a good understanding of Quality Control.
  • Have outstanding knowledge of GMP and related processes.
  • Be experienced in EU and FDA cGMP and regulatory requirements for the manufacture, testing and licensure of products within a biologics manufacturing environment.
  • Experienced in Quality Assurance Management and Continuous improvement

If you are looking to work within a challenging, dynamic, and rewarding environment, then TCB represents an excellent career move. This is an opportunity to be part of a growing, ambitious business where people development is critical to future success.  As we continue to expand, there will be career opportunities on a truly global scale.

TCB is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

Together with a competitive salary (reviewed annually), we offer a comprehensive range of benefits and an excellent working environment. 

Holiday Allowance: 32 days paid holiday p.a.   Benefits include pension and free car parking

Hours:  37.5 per week Monday to Friday, normal office hours apply

Development Manager (Cellular Immunology)
Process Development Manager
Production Scientist - Lentiviral Vectors
Production Scientist or Technician
QA Specialist
Quality Auditor
QC Microbiology Scientist
Quality Support Manager
QC Microbiology Senior Scientist
Scientists or Senior Scientists - Viral Immunology
QC Materials/Sample Management Supervisor
Research Assistant - Stem Cell Biology
Scientist or Senior Scientist - Stem Cell Biology
Quality Operations Project Manager
Scientists or Senior Scientists - Cellular Immunology

Search