Connecting...

Bioprocessing QA Manager

Job description

The Bioprocessing QA Manager is responsible for managing Quality Assurance activities in the biologics facility

Job responsibilities;

  • Management of the Quality Assurance (Bioprocessing) team, including Qualified Persons.
  • The QA Manager will manage batch record reviews, batch disposition and material status control activities associated with the biologics 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.
  • 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 (Bioprocessing) 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.
  • Participation 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 take 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.
  • Communication and liaison with other departments on Quality issues, providing guidance and support to others.
  • Motivation, training, discipline and appraisal of Quality Assurance staff.
  • Acting as a designee to the Site Quality Head as required.

Job requirements;

  • Primary Degree in Scientific discipline with 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
  • Qualified Person status is highly desirable but not essential
  • Excellent knowledge of Good Manufacturing Practice for aseptic pharmaceutical manufacture as described in current FDA & EMEA regulations.
  • Demonstrable experience managing, motivating and leading a team. 
  • A high level of initiative is required
  • Excellent verbal and written communication skills are essential.
  • Strong project management and organisational skills.
  • Ability to adapt to changing priorities

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.