A leading global Pharmaceutical company dedicated to supporting customers and their businesses in ever better ways. This organisation delivers quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices and a range of services. Selling into over 100+ countries with with over 10,000 employees, this organisation is one of the largest healthcare organisations in its defined sector. Expanding heavily here in Ireland with the acquisition of a number of maufacturing sites, this business has invested heavily in its flagship manufacturing operation here in particualr and currently require a Quality Director to head up all Quality activities at the site.
- The Role of the Site Quality Leader/Director is to lead the Quality function for the site. This encompasses System Ownership responsibilities for Quality Systems and Laboratory Control Systems and ensuring that ICH Q10 compliant Quality Management Systems are in place, in use, in control and operating efficiently and effectively for all Quality Systems to ensure the site is Permanently Inspection Ready.
- The Site Quality Leader/Director is Responsible and leads the planning, implementation and control of site Quality Systems, and QA oversight of plant expansion including qualification of manufacturing and laboratory equipment, QA IT tools, utilities and Facilities and ensure the site is ready to manufacture, test and release registration and commercial batches of pharmaceutical product.
- As a member of the Site Leadership Team the role of the Quality Leader/Director is also responsible for fostering and leading a culture of partnership and inclusion with other Departments and excellence in delivery of key business drivers relating to Compliance, Supply, Strategy and Cost.
- The Quality Leader/Director is Ultimately Responsible for release and ensuring that each batch that is released has been produced and tested in accordance with the current EU and FDA GMP directives and the relevant marketing authorization(s)/proposed registrations in the case of new product transfers.
- Undergraduate degree in pharmaceutical, biological or chemical sciences.
- Training & Experience at application of Change Execution Methodology
- 10 years+ experience, including significant management roles, in a pharmaceutical manufacturing environment.
- Comprehensive knowledge of world-wide GMP regulations and expectations governing facilities, equipment and procedures for the manufacture and control of pharmaceutical product as per ICHQ7.
- Demonstrated experience of leading and driving results in continuous improvement projects (e.g. Right First Time (RFT), Operational Excellence/Lean Projects.
- Success in developing, implementing and maintaining Quality Systems and Standards at manufacturing site level in accordance with ICHQ10 key principles.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.