AssureBio has exclusively partnered with a dynamic biotechnology company located in the South of England that is looking to appoint a Head of Quality Assurance to oversee the company’s strategic approach to quality assurance.
This position will serve as an integral part of the newly formed Senior Quality Leadership Team, which will own and drive the site’s quality improvement agenda. The Head of QA will be the decision-maker for the function, with autonomy to make operational decisions for the batch release, quality systems, and GMP training teams.
- Accountable for the Quality Assurance function’s performance; responsible for establishing quality standards, targets, and measures, as well as overseeing the execution of metrics.
- Ensure that the PQS meets the licencing requirements as well as current standards, regulations, and guidance, directs the site’s use of the PQS, and, when required, supports the development and implementation of the electronic QMS.
- Responsible for ensuring that all products, procedures, and operations on the site are fit for purpose, meet necessary regulatory standards, and align with the company’s marketing objectives.
- Defines and drives the vision and strategy for the site’s QA department.
Experience and qualifications required
- Significant expertise leading teams in an operational quality setting (with a considerable amount of time spent managing QA teams).
- Experience in leading various Health Authority inspections and internal audits.
- Practical experience in a managerial position, preferably in aseptic production.
- Strong people-focused manager with leadership, coaching, and influencing skills.
- Educated to degree level.
- Eligible to be nominated as a Qualified Person (desirable).
This is a site based role with some remote working.