Job overview:  

The Quality Coordinator supports the maintenance and continuous improvement of the Quality Management System (QMS) to ensure compliance with GxP standards and global regulatory requirements. This role plays a key part in driving quality excellence through oversight of audits, CAPAs, and quality performance metrics that protect patient safety and uphold regulatory integrity.

Location: UK (Home or London Office based).

Reports to: The Quality Coordinator will report to the Director, Clinical Quality.

 Roles and responsibilities 
(Include but are not limited to): 

QMS

• Responsible to keep up to date with current and evolving regulatory requirements, including changes relating to GxP and requirements that impact the QMS
• Measure and monitor the performance of the QMS
• Generate and report KPI Weekly / monthly to internal business partners and Quality Council
• Track critical CAPA in the QMS to ensure delivery and reporting
• Act as a MasterControl superuser

Audit and Inspection

• Audit and Inspection oversight
• Monitor adherence to annual audit plans
• Measure and monitor the performance of the audit program
• Supporting audit administration where required
• Manage and track inspection outcomes
• Own and manage Compass inspection processes in consultation with Quality Leads

Quality SME

• Act as a Quality GLP SME to support the business where required
• Process flow design and reviews
• Lead investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness
• Provision of support to Quality Leaders as required

Candidate Profile:

• Broad based knowledge of the pharmaceutical industry at least 3 years’ experience in a Quality role in Pharma or Biotech
• Experience in driving quality improvements and measuring QA data
• Ability to report data accurately and deliver on time in full
• Scientific/engineering degree or equivalent combination of education and experience
• A proven understanding of GxP and Quality Management requirements as applied in the industry
• Understanding of QMS requirements a pharmaceutical environment, and experience applying techniques such as RCA root-cause analysis and CAPA
• Excellent verbal and written communication skills, including the ability to interact effectively with different audiences
• Ability to understand quality issues in a complex a highly regulated environment and make data driven recommendation/decisions and take appropriate action
• Good knowledge of GxP and pharmaceutical regulations
• Proven ability to influence and challenge others in a constructive way
• Proven ability to prioritise tasks and deliver against milestones in a fast-paced environment