Compass Pathways
Director, Quality - GCP (Contract)
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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
- 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 standards are upheld and timelines are met
- Support governance forums and contribute to decision-making on clinical program risks and readiness
- Training & Capability Building
- Develop and implement a fit-for-purpose GCP training strategy
- Ensure continuous development of internal capabilities and quality awareness
- Metrics, Reporting & Continuous Improvement
- Define, track, and report key clinical quality metrics and trends
- Identify systemic issues and drive continuous improvement initiatives
- Provide clear and concise updates to senior leadership on quality performance and risk landscape
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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)
- Strong understanding of GxP quality systems and processes (e.g., deviations, CAPA, audits, training, document control)
- Expertise in risk-based quality management and inspection readiness
- Ability to interpret complex regulatory requirements and translate into practical solutions
- Strategic thinker with the ability to operate at both tactical and operational levels
- Strong influencing and stakeholder management skills across a matrix organization
- Excellent communication skills with the ability to challenge constructively and diplomatically
- High level of integrity, independence, and sound judgment
- Proven ability to lead through complexity and drive results
- Bachelor’s degree in a scientific discipline (or equivalent experience); advanced degree preferred
- 15+ years of experience in clinical quality assurance within the pharmaceutical or biotech industry
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Benefits:
For an overview of our benefits package and compensation information, please visit "Joins us - Our Benefits".
These include flexibility & generous time off, parental & reproductive support, health & medical, mental health & wellbeing and Financial health.
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 2010). 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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