Senior Manager, Quality (GMP/GDP)

TL;DR

Senior Manager, Quality (GMP/GDP): Overseeing quality compliance for commercial product launches in the biotech sector with an accent on GMP and GDP standards. Focus on establishing distribution networks, ensuring inspection readiness, and managing risk across the global supply chain.

Location: Must be based in the UK (Home-based or hybrid in London)

Company

Biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, specializing in synthetic psilocybin treatments.

What you will do

• Execute the Quality Commercial Readiness strategy for product launches.
• Define and track readiness criteria across GMP (manufacturing, QC, release) and GDP (distribution, logistics, temperature control).
• Oversee the qualification of logistics providers and distribution partners to ensure cold chain management and product integrity.
• Collaborate with Manufacturing, Supply Chain, Regulatory Affairs, and Commercial teams to align on timelines and risk mitigation.
• Serve as the Quality Subject Matter Expert (SME) for commercial readiness governance forums.
• Identify and manage risks impacting commercial readiness and implement mitigation strategies for compliance gaps.

Requirements

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Engineering, or a related field.
• 10+ years of experience in Quality within the Pharma, Biotech, or Life Sciences industries.
• Deep knowledge of EU GMP, FDA 21 CFR Parts 210/211, and GDP Guidelines.
• Proficiency in serialization, supply chain compliance, validation lifecycles (IQ/OQ/PQ), and eQMS systems.
• Must have existing employment rights in the UK; no visa sponsorship is available.

Nice to have

• Experience with US product launches.
• Experience working with CMOs/CDMOs.

Culture & Benefits

• Commitment to diversity, equality, and a workplace where everyone's wellbeing matters.
• Reasonable accommodation provided during the interview process.
• Opportunity to work on pioneering treatments for treatment-resistant depression and PTSD.