A global Biotech based in Dublin is looking to hire a Quality Assurance Manager with eligible Qualified Person status who will play a business critical role in establishing, developing and growing quality operations as the business progresses from clinical to commercial stage launch for advanced biologics products manufactured on-site.
The Quality Assurance Manager will be a key leader at new state-of-the-art manufacturing operations responsible for the management and development of the Quality Assurance function, leadership of QMS implementation, developing a specific new batch release process, and supporting strategic oversight of the short/mid/long term objectives for the site.
The group are a multinational, research driven biotech who have consistently been at the leading edge of drug development. This new facility is part of continued investment into their next generation pipeline in biologics.
- Establishing, developing and growing quality assurance operations ready for commercial launch and batch release.
- Management and development of the Quality Assurance function - including Qualified Person reports and additional QA staff
- Leadership of bespoke and fit for purpose QMS implementation
- Development of a new and complex batch release process specific for this product portfolio.
- Support strategic oversight of the short, mid & long-term vision of the site
- Qualified Person for the release of advanced therapy products in accordance with EU Directive 2001/83/EC.
- QA oversight of manufacturing, testing and relating activities to ensure on-going cGMP compliance.
- Implementation of Key Performance Indicators within the Quality Assurance area,
- Deviation management, ensuring effective root cause analysis and CAPAs.
- Management of the Change Control process associated with manufacture and testing,
- Support site internal audit and participation in the preparation and hosting of external health authority audits
Key experience required:
- 2-3+ years' experience in a senior quality assurance role within a sterile manufacturing operation (this is essential as you would be leading the implementation of the batch release process and supporting QMS)
- Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC
This is a leadership level role at the forefront of new-age drug development and launch for a leading high-growth pharmaceuticals group. If this looks like a great opportunity for you then please apply as soon as possible as applications are already being considered with a view to arranging interviews in the next couple of weeks.
The salary on offer is €85,000 to €95,000 and can be higher for a candidate that brings very relevant experience. There is an excellent benefits package on offer as part of the remuneration.
You can apply by the link or contact James Ivall at Goodman Masson directly on +44 2073 240538 should you want to discuss further.