Assoc Dir., Clinical Quality Mgmt. Lead

Overview

In this role you will be the expert steering risk-based quality management across global clinical development. You’ll embed quality principles early in trial design and oversee continuous quality improvements to keep trials inspection-ready. You will partner with CROs, vendors, and international teams to define tolerance limits, manage risks, and support regulatory inspections. This position offers impact across therapeutic areas in Oncology, Neurology, and Fertility within a diverse, inclusive culture. Join us to help ensure safe, effective medicines and devices reach patients at scale.

Pay / Benefits

inclusion and belonging culture
personal development and career advancement
global opportunities
flexible working arrangements
employee well-being programmes
competitive compensation

Responsibilities

Serve as SME in risk-based quality management across the clinical development lifecycle
Lead implementation and continuous improvement of quality processes to identify critical data and processes and proactively manage risks
Ensure trials are consistently inspection-ready and support regulatory inspections
Collaborate with CROs, vendors, and international study teams to define quality tolerance limits and maintain risk management plans
Lead investigations and responses to quality issues to drive continuous improvement across trials
Support risk-based monitoring strategies and maintain GCP inspection readiness throughout the trial lifecycle
Co-lead preparation for regulatory authority inspections

Key requirements

Degree in medical science, life science, or related field (postgraduate preferred)
At least eight years experience across the full clinical development lifecycle (design, start-up, conduct, analysis, reporting)
Deep expertise in clinical quality risk management, Quality by Design, risk-based monitoring, and GCP inspection readiness
Strong regulatory knowledge and familiarity with international harmonisation guidelines
Experience supporting or co-leading regulatory inspections and maintaining inspection-readiness tools and plans
Experience working with CROs and external vendors in an international, cross-functional matrix environment
Strong analytical and project management abilities; ability to translate data into actionable insights
Clear, confident communication with diverse audiences; influencing without authority
Proactive, accountable, and capable of independent work in a multinational setting
Willingness to coach colleagues and support continuous improvement