Associate Director GCP Quality Systems

Our client is seeking an experienced quality leader to drive the implementation and alignment of global R&D quality strategies across international and affiliate operations. This role ensures that local teams maintain strong, efficient, and compliant Quality Management Systems (QMS) tailored to both global expectations and regional regulatory requirements.

Key Responsibilities

1. Ensure alignment of global quality policies, procedures, and compliance expectations at the regional and affiliate levels.
2. Support local teams in establishing fit-for-purpose QMS that integrate global standards while addressing regional regulatory nuances.
3. Lead initiatives in Risk-Based Quality Management (RBQM) and Quality by Design (QbD), embedding proactive quality measures into R&D processes.
4. Act as a key liaison between global headquarters and affiliates, providing guidance on QMS implementation and compliance optimization.
5. Assess quality systems and recommend improvements that balance regulatory adherence with operational flexibility.
6. Develop and maintain metrics tracking quality and compliance across affiliates, using data-driven insights to identify trends, risks, and opportunities for improvement.
7. Partner with business and quality representatives to refine processes, identify risks, and embed quality best practices into R&D operations.
8. Support local affiliates in preparing for audits and regulatory inspections, ensuring alignment with global inspection readiness strategies.

What We’re Looking For

1. Deep knowledge of global GCP, FDA, EMA, MHRA, and ICH regulatory frameworks.
2. +6 years of experience in R&D quality assurance.
3. Proven ability to develop and implement quality systems and processes in a global setting.
4. Strong problem-solving skills with the ability to analyse complex data and trends to drive quality improvements.

This role offers the opportunity to shape quality strategies on a global scale, ensuring that R&D activities maintain the highest compliance and operational excellence. If you're passionate about driving quality transformation in a dynamic, international environment, we’d love to hear from you!

Seniority level

Director

Employment type

Full-time

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing and Biotechnology Research