An early stage cell and gene therapy business developing a proprietary delivery platform for a new generation of advanced therapies. Backed by recent private funding, the company is growing through co development and licensing partnerships with larger pharmaceutical organisations while advancing its lead programmes towards the clinic, supported by a growing platform based pipeline.

The Role

The Head of Quality will build and lead the quality function as the lead programmes progress towards clinical manufacture. This is a foundational role. It involves designing a phase appropriate quality management system that fits an advanced therapy platform, embedding the right standards early without slowing the science, and owning quality across external manufacturing partners.

It suits someone who enjoys building rather than inheriting, and who understands how to apply GMP thinking pragmatically in a small and fast moving company. The environment is operationally demanding and expects its quality leader to move at the same pace.

Key Responsibilities

• Build, implement and own the quality management system, keeping it phase appropriate, scalable and fit for an advanced therapy platform.

• Set the GMP quality strategy as programmes advance towards clinical manufacture and first in human studies.

• Lead quality oversight of external manufacturing partners and CDMOs producing advanced therapy products, including quality agreements, audits, batch review and release oversight.

• Ensure compliance with EU and US GxP requirements for advanced therapy medicinal products, including the relevant ATMP provisions.

• Maintain inspection readiness and lead regulatory inspections from agencies including the FDA, MHRA and EMA.

• Provide quality and CMC input into regulatory submissions such as CTAs, IMPDs and INDs.

• Own deviation, CAPA, change control and document management, building processes that are robust yet proportionate and support sound quality decision making.

• Lead supplier qualification and material controls, and drive continuous improvement across quality systems and manufacturing processes.

• Grow a strong quality culture across a research led team so that good practice is designed in from the outset.

Essential Experience

• A strong life sciences background with substantial quality experience in biologics, cell and gene therapy or advanced therapies.

• Proven experience building or scaling a quality management system in an early stage or growing biotech.

• Sound knowledge of EU GMP, including the ATMP framework, alongside the US equivalents.

• Direct experience overseeing CDMOs and third party manufacturers.

• Familiarity with the quality demands of clinical stage development and regulatory filings.

• Experience working with complex manufacturing operations and cross functional stakeholders.

• A strategic mindset with the ability to balance quality, compliance and business objectives.

• A pragmatic and phase appropriate approach, comfortable being hands on in a lean team.

Desirable Experience

• Qualified Person eligibility.

• Oversight of sterile or aseptic manufacturing processes.

• Direct involvement in agency inspections at an early stage company.