Manager/Senior Manager, QA Operations

About the role

Axsome Therapeutics is seeking a Manager/Senior Manager, QA Operations, responsible for ensuring compliance with Good Manufacturing Practices (GMP) with all work performed. The Manager/Senior Manager, QA Operations will contribute towards the enhancement of Axsome quality processes and ensures appropriate QA oversight of suppliers (CDMOs and GMP-related service providers) contracted for the development, manufacturing, testing, shipment and/or distribution of API and finished products to assure compliance with company procedures, FDA/EEA/Health Canada regulations and assists with tasks necessary to achieve department and/or company goals.

Responsibilities

• Assist with development and/or implementation of corporate quality management systems that support clinical-stage R&D and commercial programs
• Interact closely with Quality Systems & Compliance to champion continuous improvement and garner corporate support for Quality Improvement Initiatives
• Support the development of key performance indicators (KPIs) to measure and report operational performance of CMOs, recommending data-driven decisions to optimize processes
• Responsible for all aspects of QA Operations, including review and approval of cGMP-related documentation (SOPs, batch records, validation protocols, technical reports, specifications, deviations, CAPA, change controls, APQR) and resolve discrepancies as needed
• Identify and address compliance issues to ensure Axsome’s QMS is maintained in a state of inspection readiness
• Serve as a Quality liaison between Axsome and suppliers
• Serve as an escalation point for CMO quality issues with regards to investigations, nonconformances, deviations, and CAPA
• Alerts senior management of significant quality, compliance and supply risks
• Collaborate with internal cross-functional teams to identify and address quality issues develop corrective action plans, and implement process improvements
• Collaborate with