Director Quality Assurance Gcp

Director, QA (GCP)

Full-time, Permanent

London- Hybrid Model

Summary:

I am currently working with a pioneering biotech reshaping healthcare through genetic engineering and personalized medicine.

In this crucial position, as the Director QA GCP, your responsibility will be to assist upper management in guaranteeing that Quality remains a central focus in all corporate endeavors. More specifically, you will serve as a consultant to the Clinical Development teams, providing guidance on GCP activities related to quality.

Primary Responsibilities:

• Defining, maintaining, and monitoring the GxP Quality Management System (QMS).
• Making sure the QMS meets all the necessary regulatory requirements, with a strong focus on GCP compliance.
• Supporting and guiding the Clinical Development teams in defining compliant procedures within GxP functions and effectively managing quality issues.
• Handpicking and documenting responsibilities for external contracted organizations that support the GxP activities.
• Keeping a close eye on the performance of the GxP service providers to ensure they meet the relevant quality standards.
• Taking the lead in developing and managing the clinical audit program.
• Jumping in for GCP audits when they need to be conducted at a moment's notice.
• Maintaining quality metrics and dashboards to help communicate compliance performance, risks, and identified issues to senior management.

Education needed:

• A scientific degree, ideally in pharmaceutical science, biology, chemistry, or a related field.