This global healthcare company is committed to improving the health and well-being of people all over the world by developing, producing, and providing innovative healthcare services and solutions in more than 110 countries globally. With more than 20,000 employees in 30 countries around the world, this biopharmaceutical leader improves the lives of patients who suffer from many chronic, rare, prevalent and sometimes life-threatening diseases. With a significant R&D pipeline and a diverse commercialised product portfolio in therapy areas such as immunology, hepatology, and intensive care to name but a few, this organisations has increased year on year it's investment in Ireland, in addition to the widened scope of roles positioned at it's operation in Dublin, which is a state of the art biologics manufacturing plant and one of the premier sites in Dublin. With it's continued expansion in Ireland and internationally, a need has arisen in the organisation for a Site Quality (Technical) Director to lead all quality operations at this growing site, at an opportune time to join the business.
- The Site Quality (Technical) Director manages all QA (Quality Assurance), QC (Quality Control), Quality Systems & Compliance and GDP (Good Distribution Practice) functions at the businesses Dublin biologics manufacturing site. This includes management of RP's (Responsible Persons) and QP's (Qualified Persons).
- The position is responsible for the development of all policies, practices, procedures and specifications applicable to the organisation's products manufactured at the Dublin biologics manufacturing site, ensuring the quality, safety and efficacy of these products and their adherence to the organisations Corporate Quality Policies, to the GMPs, applicable regulations and the corresponding licenses or marketing authorisations.
- The Site Quality (Technical) Director for the Dublin biologics manufacturing site must guarantee that Qualified Persons/Responsible Persons can exercise their functions and responsibilities in accordance with the provisions of the GMPs and applicable legislation.
- They will interface with other members of the Senior Management Team, at their respective sites as well at other global locations, technical departments, customers, suppliers and regulatory agencies in the review of issues and data.
- A BSc / MSc in Science, pharmacy, or related discipline.
- A minimum of 10 years' GMP/GDP experience.
- QP qualification is preferred but not required.
- Strong understanding of biology, chemistry, and microbiology scientific disciplines.
- Ideally a strong knowledge of aseptic filling processes.
- Excellent understanding of GDP and GMP regulations and guidelines.
- Excellent understanding of suppliers' standards and guidelines.
- Previous experience in leading/managing teams.
To learn more about this role apply online or contact Shane Browne at HRM Search Partners on + 353 1 6321865 for a confidential discussion.