Director, Quality - GCP (Contract)

Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care. The Company is headquartered in London, UK, with a U.S. office in New Jersey. We believe mental health patients deserve the possibility of a better future. Our initial focus is developing COMP360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP360 is a potentially first-in-class treatment and has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD. We are leading the world’s largest classic psychedelic clinical program in TRD, and building upon that robust foundation, we are executing a late-stage trial evaluating COMP360 for PTSD, another condition with high unmet need. Our goal is to advance treatments that move the field of psychiatry towards treatment options that offer rapid onset and sustained durability with infrequent dosing. - Compass Pathways 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. The role operates with a high degree of independence, providing objective quality oversight and driving a culture of proactive quality and continuous improvement. Reports to: VP, Quality. Location: United Kingdom (Home-based or office-based/hybrid in our London office). Duration: 6 -month contract. Roles and responsibilities (Include but are not limited to) : 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 Cross-Functional Partnership Act as the primary GCP QA advisor to R&D and external partners Collaborate closely with CROs and vendors to ensure quality st…