Quality Assurance Director- ATMP

Hertfordshire (GB)
£80,000 - £90,000 + package
08 Jan 2021
07 Feb 2021
Quality, QA / QC
Full Time
Contract Type
Experience Level
Senior Management

RBW are working on behalf of an international biotechnology company who focus on gene therapy to offer life-changing cures to people suffering from chronic diseases.

They are currently seeking a QA Director, to take responsibility for supporting PQS and GxP compliance activities.

Role Functions

  • Line management responsibility for UK-based QA Managers
  • Assist VP QA with QMS design, implementation and maintenance activities
  • Ensure a compliant and efficient QA framework and operation to enable GMP activities
  • Ensure efficient QA framework operation to enable QA oversight of work executed at third-party GxP service providers
  • Lead complaint investigations and participate in recalls
  • Perform self-inspections of activities performed by Systems, Documentation and Training team and assist with audits of other QA departments as required
  • Responsible for Site Master File (SMF)
  • QA approval of risk assessments and Control Strategies
  • EU GxP regulatory surveillance
  • Efficient operation of the vendor assurance programme and maintenance of the Approved Supplier List
  • Support the team, providing guidance and technical /QA input into Change Controls, Deviations, OOS reports, investigations and CAPAs
  • Lead Quality investigations and perform risk assessments as required
  • QA Lead for qualification, validation and technology transfer activities at UK sites
  • Review annual GxP audit schedules, conduct external audits of GMP service providers and internal audits of QMS elements and selected GxP processes
  • Co-host Competent Authority inspections

Technical Qualification Requirements

  • Degree in a biological or physical science
  • Experience in the pharmaceutical industry, minimum fifteen years ‘hands-on’ GMP experience of which at least ten must be in a QA role and at least two years’ experience working with ATMPs- must have excellent knowledge of ATIMP
  • Competent Authority (e.g. MHRA, US FDA) inspection experience
  • Prior experience auditing contract manufacturers and suppliers
  • Awareness and understanding of GCP requirements
  • Trainee or aspiring Qualified Person – existing QP status would be an advantage but not essential

Personal Skill Requirements

  • Ability to work in a small team in a dynamic environment
  • Excellent planning and organisational skills
  • Excellent interpersonal skills
  • Excellent verbal and written communication and computer literacy skills
  • Effective time management
  • Strong analytical and problem-solving skills
  • Ability to travel to work partners in Europe and US as the role requires

The role will be a mix of home working and office time in Hertfordshire. If you are interested in this position and would like to find out more, please get in touch for more information. You can contact Katie Dunbar on +44 (0) 1293 584 300 or use the apply button on this page.