Description

Quality Assurance Manager (Clinical & CMC)

Location: hybrid, remote and on-site in London

Overview

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.

Key Responsibilities

• 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 & Background

• Experience in Quality Assurance within biotech or pharmaceutical environments
• Exposure to clinical and/or CMC quality (either or both)
• Experience within 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

Personal Attributes

• 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

Why This Role

• 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