Job Description

Quality Coordinator
Location: London
Employment Type: Full-time
Salary: £72K–£96K a year
PCD290096

Role Overview
Position: Quality Coordinator New United Kingdom
The organisation (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments.
We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP
360 synthetic psilocybin treatment, potentially a first in class treatment. COMP
360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area.
We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive.
• the organisation.
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 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 Master Control 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 the organisation 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 three 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.