Quality Coordinator

2 weeks ago

London, Greater London, United Kingdom Compass Pathways Full time £40,000 - £60,000 per year

Company introduction:

Compass Pathways plc (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 COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 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. - Compass Pathways.


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 QMSMeasure and monitor the performance of the QMSGenerate and report KPI Weekly / monthly to internal business partners and Quality CouncilTrack critical CAPA in the QMS to ensure delivery and reportingAct as a MasterControl superuser

Audit and Inspection

Audit and Inspection oversightMonitor adherence to annual audit plansMeasure and monitor the performance of the audit programSupporting audit administration where requiredManage and track inspection outcomesOwn and manage Compass inspection processes in consultation with Quality Leads

Quality SME

Act as a Quality GLP SME to support the business where requiredProcess flow design and reviewsLead investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectivenessProvision 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 BiotechExperience in driving quality improvements and measuring QA dataAbility to report data accurately and deliver on time in fullScientific/engineering degree or equivalent combination of education and experienceA proven understanding of GxP and Quality Management requirements as applied in the industryUnderstanding of QMS requirements a pharmaceutical environment, and experience applying techniques such as RCA root-cause analysis and CAPAExcellent verbal and written communication skills, including the ability to interact effectively with different audiencesAbility to understand quality issues in a complex a highly regulated environment and make data driven recommendation/decisions and take appropriate actionGood knowledge of GxP and pharmaceutical regulationsProven ability to influence and challenge others in a constructive wayProven ability to prioritise tasks and deliver against milestones in a fast-paced environment Benefits & Compensation:

For an overview of our benefits package and compensation information, please visit  "Working at Compass".  

Equal opportunities: 

Reasonable accommodation

We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. 

UK applicants

We are proud of our commitment to diversity and equality (pursuant to the Equality Act We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.

US applicants

Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.

Sponsorship:

Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.

Data Privacy:

All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

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