An industry leading commercial pharmaceuticals group with a network of global locations is looking to hire a Lead Qualified Person for their team in Greater 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 Lead Qualified Person, you will head the release of a range of flagship sterile product lines that are developed on-site and at multiple CMO locations. You will also take full ownership of all quality aspects for new commercial NPI projects that are being launched. This is a hands on, 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 Lead 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.
To be considered for interview, you will need to have the following experience:
- Prior QP release experience
- 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 become a senior QP in a stand-alone role. i.e. the ability to work autonomously with minimal supervision
A salary of up to €100,000 is on offer to attract a great candidate. There is also a very good benefits package on offer with full flexibility on working hours.
This Lead Qualified Person vacancy is a key hire and the intention is to shortlist CV's before Christmas to arrange interviews at the earliest opportunity. Please apply as soon as possible to be considered. You can also contact James Ivall at Goodman Masson should you have any questions or want to discuss the role in more detail prior to applying.
Hope to hear from you soon.