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.

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.

Roll

Director, Quality - GCP (Contract)

Kategori

Quality

Plats

London

Publicerad

27 maj

Sista ansökningsdag

16 augusti

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