Associate Director Quality Assurance

About the Organisation

A
science-led, international life sciences company
operating in a highly regulated development environment is expanding its Quality function. The organisation works across early and clinical development stages and partners extensively with external service providers globally.

Role Overview

We are hiring a
Senior Manager / Associate Director, Clinical & Preclinical Quality
to support development activities across clinical and non-clinical programs. The role works closely with senior quality leadership and cross-functional stakeholders to ensure strong
GCP and GLP compliance
, robust data integrity, and inspection readiness.

This is a
hands-on quality role
suited to an experienced professional with a strong background in
clinical quality, preclinical/GLP oversight, and early development
, who is comfortable operating in a dynamic, international environment.

Key Responsibilities

Clinical Quality (GCP)

• Provide quality oversight for multiple clinical development activities
• Support GCP compliance across internal teams and external partners
• Contribute to inspection readiness and regulatory interactions
• Review and approve clinical quality documentation and procedures

Preclinical / GLP Oversight

• Provide quality oversight for preclinical, toxicology, and laboratory studies
• Plan, conduct, or manage GLP audits of CROs and external laboratories
• Ensure studies are conducted in line with GLP requirements and internal standards
• Support program transition from early development into clinical stages

External Partner Oversight

• Execute and manage audits of CROs, laboratories, and service providers
• Support CAPA management and continuous improvement activities
• Contribute to vendor qualification and ongoing oversight

Quality Systems & Compliance

• Support the development and maintenance of GCP/GLP quality systems
• Contribute to internal training on quality and compliance requirements
• Promote strong documentation practices and data integrity

Experience & Background

Required

• 5–10+ years' experience in
  GCP Quality Assurance
  within biotech, pharma, or CRO settings
• Hands-on experience with
  GLP and preclinical program oversight
• Experience supporting
  early development and translational activities
• Proven track record conducting and managing
  vendor and CRO audits
• Solid knowledge of
  ICH, GCP, GLP, and global regulatory expectations

Preferred

• Experience in
  growing or evolving organisations
• Exposure to complex or regulated development programs

Skills & Attributes

• Highly organised, detail-oriented, and quality-focused
• Strong communication and stakeholder management skills
• Comfortable working both independently and collaboratively
• Able to balance strategic thinking with hands-on execution