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Quality Assurance Manager

2 months ago


Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full time
About the Role

We are seeking a highly skilled Quality Assurance Manager to join our team at Pharma Partners Recruitment Ltd. As a Quality Assurance Manager, you will play a key role in maintaining and monitoring our Good Clinical Practice (GCP) Quality Management System (QMS) to ensure compliance with regulatory requirements and standards.

Key Responsibilities
  • QMS Maintenance and Monitoring: Ensure our GCP QMS meets all regulatory requirements and standards, with a focus on GCP compliance.
  • Support to Clinical Development Teams: Provide support to our Clinical Development teams in defining compliant procedures within GxP functions, managing quality issues, and ensuring external contracted organizations meet quality standards.
  • Quality Metrics and Dashboards: Maintain agreed quality metrics and dashboards to enable clear communication to senior management of compliance performance and any risks or issues identified.
  • Regulatory Compliance: Maintain awareness of, and ensure compliance with, policies and procedures relating to quality standards within the company.
Requirements
  • Experience: Minimum 2+ years in a similar role, preferably in a biotechnology or biopharmaceutical environment.
  • Skills and Knowledge: Substantial experience of successfully managing quality issues, proven track record in defining, implementing, and maintaining Quality Management Systems, and comprehensive knowledge of GCP requirements.
What We Offer

A highly competitive salary, stock options, annual bonus, and wider benefits package are on offer. You will be required to work onsite in Cambridge 2 times a week.