Case Study: Enabling an early-stage client to hit project timelines by hiring their first QA team

Hobson Prior was approached by an early-stage biopharmaceutical client, whom we’d supported across other functions like Clinical operations, Regulatory & Technical operations but never within Quality Assurance.

They needed immediate support, in their search for an Interim Head of Quality Assurance to continue the progress of their pipeline, it was vital they engaged with a GMP QA consultant to carry out a GAP analysis of the QMS, be part of the CMO selection and technology transfer of a pipeline candidate to keep them on track with project timelines.

The senior leadership team are well connected, from their time at large pharmaceutical companies. Between them, they explored their networks but on this occasion, could not find anyone suitable to take up this position within the needed timeframes.

The struggle for our client was finding Quality Assurance professionals at the right level of seniority with immediate availability, that could write the Quality plan for a technology transfer of their sterile manufacturing process to CMO.

Initially, our client held a briefing call with Hobson Prior and their two other top-tier agencies. They made it clear that experience writing quality plans for sterile technology transfer processes as well as strong CMO management, was the expertise needed at an absolute minimum. Knowledge and exposure working to EMA and MHRA guidelines were essential with FDA being a plus. They needed someone independent and skilled enough to write this plan independently with little management or guidance.

I personally have spent a lot of time proactively building my network within this space, it consists of both contract and permanent members of staff across different seniority levels throughout the UK, EU & US. – My first approach was contacting the relevant professionals within my network whom I knew had written quality plans for technology transfers, starting in the UK and working out through Europe.

From my network, I had two people shortlisted and six referrals of people that may have the right experience. My next move was to begin conversations with the six suggested names of people that I had not spoken to before; we discussed the opportunity, their relevant experience and availability – I shortlisted two more applicants, bringing my shortlist total to four.