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Helping an early-stage biopharma build their first QA function 

Case study
Posted 15 August 2022
2 mins read

When a fast-moving biopharmaceutical company needed to hire their first Quality Assurance leader, they turned to R&D Partners. With critical milestones approaching, they needed someone who could hit the ground running fast. 

Key stats 

  • 4 qualified candidates submitted within 3 working days 
  • 1 Interim Head of QA hired and onboarded within 10 days 
  • No delays to CMO selection or technology transfer timelines 

The situation 

An early-stage biopharma, already partnering with R&D Partners across Clinical, Regulatory, and Technical Operations, approached us with a new challenge: hiring their first QA leader. 

They needed an Interim Head of Quality Assurance to conduct a GAP analysis of their QMS, support CMO selection, and lead the quality planning for a sterile manufacturing technology transfer. Despite strong internal networks, they couldn’t find someone with the right experience and immediate availability. 

The brief was clear, they needed a senior GMP QA consultant with experience writing quality plans for sterile tech transfers, strong CMO management skills, and familiarity with EMA and MHRA guidelines (FDA exposure a bonus). Independence and speed were non-negotiable.

The solution 

We began with a competitive briefing alongside two other top-tier agencies. Drawing on a network I’ve built over years of proactive engagement in the QA space, I immediately reached out to trusted professionals across the UK and Europe. 

From my network, I shortlisted two candidates and received six referrals. After screening the referrals, I added two more to the shortlist, bringing the total to four highly qualified applicants. 

Each candidate underwent a final screening call to assess technical fit, communication style, and motivation for the role. Only after this rigorous process did I submit the shortlist to the client. 

The result 

Within three working days of the initial briefing, all four submission slots were filled. Two candidates progressed to interviews, and an offer was made and accepted within 10 days. 

The new Interim Head of QA was able to begin the GAP analysis immediately, keeping the CMO selection and tech transfer process on track. The second finalist is now being considered for another role within the business. 

R&D Partners remains a top-tier supplier for this client, who praised our speed, precision, and understanding of their needs. 

From first hire to future-ready 

Building a QA function from scratch takes more than expertise, it takes a partner who understands your pace and priorities. If you’re scaling your quality team or launching a new function, we’re ready to help. Let’s talk about how we can support your next milestone. 

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