Interim Head of Quality
Our client, based in the Southeast of England, is a well-known SME life sciences company with unique and pioneering technologies that are already delivering therapeutic product candidates into the clinic.Manufacturing of clinical material is currently outsourced to CMO’s, although this will change when the company relocates to brand-new, custom-built premises that will house both the current R & D Group and a new state of the art manufacturing facility. This facility will then produce material for the planned Phase III trial through to market authorization and commercial supply.
In bringing on-line its own manufacturing facility, our client will take the final step in the “Quality Journey” from an R & D company to a cGMP manufacturer seeking marketing authorization. A pragmatic and fit-for-purpose quality system with a high level of compliance is a critical element for economic success.
This represents a significant step change for the current QA function and a major change management programme throughout the organisation.
The need therefore exists for a highly experienced Interim Head of Quality who will:-
- Build a fit-for-purpose Quality Management System
- Deliver a Master Validation Plan
- Deliver a full suite of IQ, OQ PQ validation protocols and reports
- Deliver a process validation package for the revised manufacturing process
- Deliver a site master file for manufacturing licence
- Establish an in-house QC function
- Lead the development of a Quality culture within the company
- Achieve a Marketing Authorisation for the company’s new facility
This is a very challenging assignment that will stretch even the most experienced of Quality professionals. The assignment is expected to be of 9-12 months duration, ideally as close to 5 days / week as possible. Candidates must have :-
- Long experience of leading QA / QC functions, ideally in SME biotech operations
- Experience of GLP, GMP and GCP
- Experience of building and validating biotech manufacturing plants
- A track record of change management – vision and communication
- A track record of implementing quality management systems
If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible. Phone 01844 – 202989 or email to gn@interea.co.uk
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