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Clinical Stage Oncology Company - Quality Team Build-out Project

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Challenge

Challenge

This organisation has an excellent leadership group with most functions covered, however there was a need to build a world class Quality Assurance group to cover all GXP functions and implement corporate SOPs and QMS to support clinical trials, material supply and future scale up to commercial production.

Solution

The two key hires were the VP and Senior Director. The VP’s background is predominantly GMP, this blended well with the Senior Director of QMS, who has a strong background in Clinical Quality. Given the depth of experience of both individuals, the group leaders were well balanced. Further operational support was needed and as such two individuals were required to complete the group. (Associate Director of GCP & QMS).

·         Timeline - 4 months total completion time

·         Additional research material provided:

o   Full nationwide market maps of approx. 100 candidates per role

o   Real time market information on compensation packages

o   Insight into peer company management structures

o   Consultation and debrief on industry challenges 

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Outcome

Working directly with the CEO and other leaders of the group, we were able to provide a flexible and highly consultative and cost-effective solution which provided the client access to a range of highly screened and well referenced candidate options. This led to a well-balanced Quality group that is fit for purpose within an aggressive timeline.

Placements made:

·         VP Quality

·         Senior Director of Quality Management Systems

·         Associate Director of Clinical Quality

·         Associate Director of Quality Management Systems