Über diese Director, Quality - GCP (Contract) Stelle bei Compass Pathways
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 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 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
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
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 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.
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