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Compass Pathways · 4 weeks ago

Senior Manager, Clinical Quality

New York, United States

Full-time

Onsite

Senior Level

Compass Pathways plc is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Senior Manager, Clinical Quality is responsible for developing and implementing a risk-based GCP audit program, ensuring compliance with regulations, and supporting regulatory inspections.

BiotechnologyHealth CareLife ScienceMental HealthPersonal HealthWellness

Growth Opportunities

No H1B

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)

Qualification

GCP auditingClinical trial operationsGCP guidelines knowledgeLeadership skillsProject managementAnalytical skillsCommunication skillsProblem-solving skillsTeamwork