Senior Manager, Clinical Quality

Compass Pathways•New York, NY

3d•Remote

About The Position

The Senior Manager, Clinical Quality is responsible for developing and implementing a risk-based GCP (Good Clinical Practice) audit program. This includes planning and conducting audits, coordinating the activities of independent QA auditors, and supporting regulatory inspection readiness activities and regulatory inspections by EMA, FDA and other competent authorities. The role contributes to quality risk management and continuous improvement across clinical trials and related processes.

Requirements

Degree in a life science field or a related clinical research area (preferred)
GCP QA professional with broad drug experience which spans all clinical phases (Phase I to IV)
Extensive experience in GCP auditing and clinical trial operations
In-depth knowledge of GCP guidelines (ICH-GCP) and regulatory requirements for clinical trials
Strong understanding of clinical trial design, conduct, and data management
Excellent leadership, communication, and interpersonal skills
Strong analytical and problem-solving skills
Ability to work independently and as part of a team
Excellent project management skills
Alignment with the Compass values

Responsibilities

Provision of GCP QA advice and support to clinical project teams and cross-functional departments to help ensure compliance with applicable regulations and internal quality standards
May act on behalf of the Director, Clinical QA, to provide leadership support and ensure continuity of QA oversight and decision-making
Manage GCP audits of sites, documents, databases, vendors, or internal systems in compliance with GCP and Compass quality standards
Coordinate activities of external auditors, during the preparation, conduct and reporting of GCP audits
Support, and conduct when required, risk-based audits of clinical trial sites, both internally and those managed by CROs (Contract Research Organizations), vendors and internal systems ensuring adherence to GCP guidelines, protocols, and regulatory standards
Support the preparation of comprehensive audit reports, identifying potential issues and recommending corrective actions for internal teams and collaborating with CROs to implement necessary changes
Work closely with internal teams to ensure alignment with GCP expectations to address findings and action items from audits
When required, lead investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness
Proactively assess compliance issues and risks; serve as the expert GCP consultant for issue management & issue escalation
Support 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
Support the management of GCP inspections within Compass and at vendors/partners of Compass studies and/or processes, as required
Liaise with regulatory agencies (e.g., FDA, EMA) regarding GCP compliance matters
Stay up-to-date on evolving GCP regulations and best practices in clinical trial audit methodology
Participate in the development and implementation of training programs for clinical trial staff, both internal and at CRO partners, on GCP and regulatory compliance
Contribute to the development and review of standard operating procedures (SOPs)