Quality Assurance Manager

Quality Assurance Manager (Clinical & CMC)

Location: hybrid, remote and on-site in London

An innovative, early‑stage advanced therapeutics company is seeking a Quality Assurance professional to support its transition from external consultancy to an in‑house QA function. This role will sit at the heart of clinical and CMC activities, working cross‑functionally to ensure quality oversight as the organisation continues to scale.

The successful candidate will be hands‑on, pragmatic, and commercially aware
, with the confidence and EQ to challenge and influence internal stakeholders without slowing execution.

• Provide QA oversight across clinical and CMC activities
  , supporting ongoing and upcoming programmes
• Act as the primary internal QA point of contact,
  replacing existing QA consultancy support
• Support and maintain the Quality Management System (QMS), ensuring compliance with applicable GxP requirements
• Review and approve key quality documentation, including SOPs, protocols, reports and vendor documentation
• Support vendor oversight (e.g. CROs, CDMOs, laboratories) from a quality perspective
• Partner closely with Clinical, CMC and other functional teams to ensure quality is embedded in execution
• Support inspections, audits and regulatory interactions as required
• Help shape and evolve quality processes appropriate for an early‑stage, scaling organisation

• Experience in Quality Assurance within biotech or pharmaceutical environments
• Exposure to clinical and/or CMC quality (either or both)
• Experience with in advanced therapies is strongly preferred (e.g. RNA, cell & gene, novel modalities)
• Comfortable operating in a lean, fast‑moving environment rather than a heavily layered corporate structure
• Does not need to be senior leadership level — this is a delivery‑focused role rather than a strategic QA head

• High energy, proactive, and execution‑focused
• Strong emotional intelligence — able to influence, ‘police’ quality appropriately, and build trust across teams
• Pragmatic mindset with an appreciation for speed and stage of development
• Comfortable being visible and present within an on‑site culture

• Opportunity to build and own QA internally at a pivotal growth stage
• Broad exposure across clinical and CMC activities
• Significant influence without unnecessary hierarchy
• Strong in‑office culture with flexibility evolving as the organisation matures