An amazing leadership opportunity for an experienced Quality Director to join a gene therapy company at an exciting phase of their journey has come available in Clare. Within this role you will be working directly with the UK based VP Quality to ensure that site quality objectives are aligned with the company's overall quality KPIs.
You will have 10 years' experience in Biopharmaceutical Operations where you have successfully led quality operations. You will be an experienced leader who has been part of a site management team, who is able to contribute collaboratively to the development and implementation of clear operational plans with emphasis on quality requirements.
You will have extensive knowledge and understanding of pharmaceutical Quality and GMP experience within a manufacturing start up project. This knowledge must be combined with clear decision making, pragmatism aligned with quality risk management principles to demonstrate release of product for clinical and commercial use.
You will be a strong people manager who is a positive, resilient and collaborative leader with a 'can do' approach. You will have a hands-on, operational approach, and experience with facilitating a Quality Culture and building a "Quality Mindset" for team members
The QD is responsible for the QA and QC departments on the Clare site.
- Quality Assurance: Provide end-to-end QA oversight of the manufacturing facility and support functions ensuring product (Plasmid, Investigational Medicinal Product and Commercial Drug Product) is manufactured and tested in accordance with the site licences and that all associated quality documentation.
- Quality Control: Provide end-to-end QC oversight and support. The QD will play a key role in ensuring implementation of a new QC laboratory that can undertake compliant GMP testing of Plasmids and Gene Therapy Products and associated materials intended for Clinical and commercial supply.
- The QD co-own, together with the Head of QC (UK), the QC Internalisation Strategy and is responsible for ensuring this is implemented in a timely manner in accordance with business needs.
**A highly attractive package which includes generous salary, pension and health insurance, dental care, etc is on offer **
For a confidential discussion and to review the Job Description contact Kerry on 086 044 3981