COMPASS Pathways plc is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support.
COMP360 has been designated a Breakthrough Therapy by 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). We have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. COMPASS Pathways.
The Director of Clinical QA will serve as the GCP QA expert within the Compass business and establish strong relationships with other R&D Functions. They will establish, maintain, and ensure effectiveness of GCP QA audit programs and effective GCP systems that support Compass Clinical trials.
Location: United Kingdom or East Coast, USA (home, hybrid or full office based in our London or New York City offices).
Reports to: Vice-President, Quality.
Roles and responsibilities
(include but are not limited to):
- Support the development of the GCP risk-based processes and frameworks for oversight of vendors and systems
- Define and build the GCP QA strategy and capability to support Compass clinical portfolio while maintaining a strong independent role for QA decision-making
- Develop and deliver ongoing fit for purpose GCP training
- Establish processes and procedures for GCP audit program
- Manage audits of sites, documents, databases, vendors, or internal systems in compliance with GCP and Compass quality standards
- Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks as needed.
- Provision of support to clinical quality champions in implementing corrective and preventive actions
- Lead investigations into significant quality issues, scientific misconduct, and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness
- Present clinical metrics and escalate systemic and/or critical problems to management
- Proactively assess compliance issues and risks; serve as the expert GCP consultant for issue management & issue escalation
- Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed, and closed within target timeframes
- Host and manage inspections of GCP internally and at vendors/partners of Compass studies and/or processes
- GCP QA professional with broad drug experience which spans all clinical phases (Phase I to IV)
- Demonstrated auditing experience across all types of clinical audits (phase I, investigator sites, systems, data management, statistics, labs and CROs
- Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations
- Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues
- Experience with GXP QA systems, processes, and procedures such as documentation and record management, change control, deviations, investigations, training, and CAPA
- Bachelor’s degree in a scientific discipline is required or equivalent combination of education and experience
- Considerable amount of relevant experience in a GCP audit biotech/pharmaceutical setting
- Results oriented, establishing clear expectations and priorities, sets objectives and effectively applies resources. Consistently delivers
- Flexible and creative problem-solving skills; ability to challenge current processes, practices and strategy and uncover alternative approaches, solutions, or methods
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders and who is enthusiastic and willing collaborate with other QA leaders
- Ability to build effective relationships (internal and external)
- Excellent verbal and written communication skills, including the ability to interact effectively with different audiences
- Excellent networker with the ability to collaborate and agree outcomes
- Ability to understand quality issues in a complex a highly regulated environment