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Director of Quality Assurance GCP

3 months ago

London, Greater London, United Kingdom Albion Rye Associates Full time
Director, QA (GCP)nFull-time, PermanentnLondon- Hybrid Model

Summary:
nI 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).nMaking sure the QMS meets all the necessary regulatory requirements, with a strong focus on GCP compliance.nSupporting and guiding the Clinical Development teams in defining compliant procedures within GxP functions and effectively managing quality issues.nHandpicking and documenting responsibilities for external contracted organizations that support the GxP activities.nKeeping a close eye on the performance of the GxP service providers to ensure they meet the relevant quality standards.nTaking the lead in developing and managing the clinical audit program.nJumping in for GCP audits when they need to be conducted at a moment's notice.nMaintaining 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.