An industry leading commercial pharmaceuticals group with a network of global locations is looking to hire a Qualified Person for their site based to the north of Dublin. The role is a senior position responsible for key commercial markets and the launch of new products reporting into the Director of Quality Assurance.
As Qualified Person you will take full ownership of all quality aspects for new commercial NPI projects that are being launched and head the release of a range of flagship sterile and biologics product lines that are developed on-site and at multiple CMO locations. This is a very commercially focused quality position that will network with senior stakeholders in leading pharma's and partner with senior leadership internally to help drive the continued development of the group.
Key Responsibilities as Qualified Person:
- QP release and operational oversight of the release process.
- Ensuring continued effective QMS oversight for contract research and manufacturing organisations. Helping to drive improvement and harmonisation of processes across this network.
- Act as quality lead in support of new business generation, established product updates and new product lines.
- Management of all NPI quality & regulatory operations
- Championing quality as a key business partner for commercial operations.
- Harmonising processes across NPI and driving consistency with launch.
- Help to reduce NPI launch timeframes as quality oversight and key member of NPI project teams relating to product testing release.
- Support quality audits across CMO/CRO's to support introduction of new products to the group
- Review and approval of NPI project documentation to include validation protocols & reports, change controls, standard operating procedures.
You will have the following experience:
- Ideally prior QP release experience. However able to look at QP eligible applicants with a strong background in batch release operations.
- Sterile experience as essential
- Ideally having led a function or key quality projects or aspects in a commercial operation
- Ideally experience of supporting the introduction of new products however not essential
- Able to evidence the ability to perform in a stand-alone role. i.e. the ability to work autonomously with minimal supervision
A salary of €80,000 - €100,000 is on offer depending on prior release experience to attract a great candidate and can go higher. There is also a good benefits package on offer with full flexibility on working hours.
This Qualified Person vacancy is a key hire and the intention is to begin interviewing through January so please apply soon to be considered. You can also contact James Ivall at Goodman Masson on +44 2073 240 538 should you have any questions or want to discuss the role in more detail prior to applying.