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.

Job overview
The Director of Clinical Quality Assurance (GCP) serves as the enterprise GCP QA expert across the Compass organization, providing strategic leadership and oversight of clinical quality systems, audit programs, and compliance frameworks. This role is accountable for ensuring the design, implementation, and continuous improvement of a robust, risk-based GCP Quality Assurance function that supports the full clinical development lifecycle. The Director will partner cross-functionally across R&D to ensure clinical trials are conducted in compliance with global regulatory requirements, with a strong focus on subject safety, data integrity, and inspection readiness.

Reports to: VP, Quality
Location: London (Hybrid)
Duration: 6-month contract

Roles and responsibilities
Strategy & Leadership

• Define and execute the global GCP QA strategy aligned with organizational and clinical development objectives
• Build and scale GCP QA capabilities to support the clinical portfolio
• Maintain strong independence of the QA function while effectively influencing stakeholders across R&D
• Champion a proactive, risk-based quality culture across the organization

GCP Quality Systems & Governance

• Establish, maintain, and continuously improve GCP QA processes, procedures, and governance frameworks
• Ensure effectiveness of key quality systems (deviations, CAPA, change control, training, document management) in a GCP environment
• Provide expert guidance on regulatory expectations and evolving GCP requirements

Audit & Inspection Management

• Design and lead a comprehensive, risk-based GCP audit program covering: Investigator sites, CROs and vendors, Internal systems, processes, and databases
• Ensure audits are executed in compliance with global GCP regulations and internal standards
• Lead inspection readiness activities and act as a key Quality representative during regulatory inspections
• Oversee timely closure and effectiveness of audit and inspection CAPAs

Risk & Compliance Oversight

• Assess and interpret audit findings, deviations, and compliance risks with respect to: Subject safety, Data integrity, Regulatory impact
• Escalate critical and systemic risks to senior leadership with clear mitigation strategies
• Lead and oversee investigations into: Significant quality issues, Scientific misconduct, Serious breaches of GCP
• Ensure robust root cause analysis and sustainable CAPA implementation

Candidate Profile

• Extensive GCP QA experience across the full clinical development lifecycle (Phase I–IV)
• Proven leadership in designing and executing global GCP audit programs
• Deep knowledge of international GCP regulations and guidance (FDA, EMA, ICH)
• Strong experience managing regulatory inspections and complex compliance scenarios
• Demonstrated expertise in vendor oversight (CROs, labs, service providers)
• Expertise in risk-based quality management and inspection readiness
• Bachelor’s degree in a scientific discipline; 15+ years of experience in clinical quality assurance

Compass Pathways is an equal opportunity employer. Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the UK.