A leading pharmaceuticals and biotech manufacturer are looking to hire a Senior Qualified Person to grow out quality operations and support the introduction of the batch release process for the company's new flagship biologics product.
The Senior Qualified Person will help to establish, develop and grow quality operations as the site progresses from clinical to commercial stage launch for biologics products manufactured on-site in Dublin.
You would a key operational leader at their state-of-the-art manufacturing facility, responsible for developing the manufacturing quality release function, leading bespoke QMS implementation, and driving the growth of the quality function and site. This is a high profile and autonomous role for the group where you will be able to take the lead on setting and achieving key milestones in line with company strategy. You would be the lead named QP with the HPRA.
An excellent candidate for this role will have 3+ years of hands-on release experience in a sterile manufacturing environment with proven operational results at driving through QA project from start to finish.
As Senior Qualified Person, you would have responsibility for:
- Establishing, developing and growing quality assurance operations ready for commercial launch and batch release.
- Management and development of the Quality Assurance function - including future 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 in accordance with EU Directive 2001/83/EC.
- QA oversight of manufacturing, testing and relating activities to ensure on-going cGMP compliance
- Implementation of KPI's within the Quality Assurance area,
- Support site internal audit and participation in the preparation and hosting of external audits
You will have the following experience:
- 3+ years of hands-on Qualified Person release experience in a sterile manufacturing environment.
- Proven operational experience at driving through QA projects from start to finish.
- Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC
The salary on offer is €90,000 to €100,000 and can be higher for a candidate that brings very relevant experience. There is an excellent benefits package on offer also that includes, bonus, long-term incentives and more.
Interviews are already taking place so if this looks like a great opportunity for you then please apply as soon as possible to be considered and ensure you do not miss out. You can also contact James Ivall at Goodman Masson should you want to discuss further.
Hope to hear from you soon.