QA Manager

Job description

The Quality Assurance Manager will be responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department 


  • Management of the Quality Assurance team, including Qualified Persons.
  • Management of batch record review, batch disposition and material status control activities associated with the Cell Therapy product.  These activities will take place 24/7.
  • Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
  • The QA Manager will be responsible for management of the Change Control process, ensuring controlled implementation of all GMP related changes.
  • Management of QA oversight of manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
  • Ensuring effective participation of the Quality Assurance team in production and other site meetings.
  • Implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.
  • The QA Manager will actively participate in the site Internal Audit programme.
  • Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
  • Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
  • The QA Manager will be taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement. 
  • Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives.
  • Motivation, training, discipline and appraisal of Quality Assurance staff.
  • Acting as a designee to the Head of Quality for Cell Therapy as required.


  • Primary Degree in Scientific discipline
  • More than 7 years’ experience working an aseptic environment in the pharmaceutical industry, preferably in a Biologics company
  • Minimum of 3 years’ experience in a people management role 
  • Demonstrable experience managing, motivating and leading a team.  
  • A high level of initiative is required
  • Strong project management and organisational skills.


Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.