Head of Quality

Overview

A biologics CDMO is seeking a
Head of Quality
to lead a large, established quality organisation through a significant transformation. This is a senior leadership role with full responsibility for site Quality, covering QA, QC, Compliance and associated functions. The site has a strong commercial track record and is now transitioning into a multi-client CDMO model across multiple modalities and development phases. The role will provide the opportunity for a transformative leader to
reshape the quality organisation, implement phase-appropriate quality systems, and position quality as a differentiator for clients.

The Opportunity

This is a rare opportunity to step into a highly visible role where you will:

- Lead a
~100+ person quality organisation
- Drive a
full quality transformation
in a transitioning CDMO environment
- Build a
phase-appropriate quality framework
(clinical → commercial)
- Partner directly with clients and represent Quality externally
- Influence how quality is positioned as a
commercial differentiator
- Play a key role in a
strategic U.S. manufacturing site

Longer-term, this role offers:

- Exposure to a
global quality structure
- Opportunity to work across international sites
- Potential progression into
global quality leadership

Key Responsibilities

• Provide overall leadership of site Quality (QA, QC, Compliance)
• Assess and restructure the current quality organisation
• Implement scalable, phase-appropriate quality systems and processes
• Oversee batch release, deviation management, investigations and compliance
• Ensure ongoing inspection readiness across global regulatory bodies
• Act as the primary Quality representative for client interactions
• Partner with site leadership on operational, strategic and commercial decisions
• Support new product introduction and tech transfer from a quality perspective
• Drive cultural change within the quality organisation

What They Are Looking For

This role is less about maintaining the status quo and more about
leadership, transformation and decision making
. The ideal candidate will bring:

- Experience leading Quality within a
GMP biologics manufacturing environment
- Strong leadership experience managing
large, complex teams
- Experience operating across
clinical and commercial phases
- Ability to implement
risk-based, phase-appropriate quality approaches
- Experience interacting directly with clients in a CDMO or partner-facing environment
- Strong communication skills across all levels of an organisation

Leadership Profile

- Take ownership of a function that needs
direction and structure
- Communicate clearly both
upwards (executive level)
and
downwards (teams)
- Make
confident, timely decisions
in complex environments
- Handle difficult conversations and organisational change
- Build trust quickly and bring stability to the team
- Balance
compliance, science and business needs

Location

• On-site role in the U.S. (relocation required)
• Suitable for candidates open to relocating for a step-up opportunity or broader leadership remit

Please apply directly to this role and contact Hemish Ilangaratne for further information.