Interim Quality Consultant

The Opportunity

This is not a typical interim role.

You will be stepping into a business that is growing quickly, with real ambition, but where regulatory and quality foundations now need to catch up with that pace. There are active FDA remediation workstreams underway. Progress is being made, but they need experienced leadership to bring structure, clarity and momentum. Someone who has done this before, and knows what “good” looks like.

What You Will Be Doing

• Leading FDA remediation workstreams end to end
• Bringing structure and discipline to complex, shifting priorities
• Aligning internal teams and external partners, including CDMOs
• Supporting decision making at pace, without losing control
• Identifying gaps, risks and dependencies, and addressing them early
• Helping the business move from reactive to proactive
• This is hands-on. You will need to be visible, credible and able to operate at both strategic and operational levels.

What They Need

This is where many roles fall down, so let’s be clear. They are not looking for someone to maintain the status quo.

They need someone who:

• Has led FDA remediation programmes before, not just supported them
• Is comfortable operating in ambiguity and pressure
• Can prioritise effectively when everything feels urgent
• Challenges where needed, but brings people with them
• Is pacey, pragmatic and solutions-focused
• Understands manufacturing, supply chain and quality interdependencies
• Strong experience across FDA, GxP, and regulated manufacturing environments is essential.

The Environment

• Fast-growing business with significant ambition
• Multiple competing priorities and evolving plans
• Strong leadership team, open to challenge and change
• A genuine opportunity to make a visible impact quickly