Specialist, Quality Assurance

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About This Role 

Axsome Therapeutics is seeking a Quality Assurance Specialist/Senior Specialist to focus on ensuring compliance with Good Manufacturing Practices (GMP) with all work performed. The QA Specialist/Senior Specialist will provide the Quality Assurance team oversight of external manufacturing activities to ensure consistent compliance with company procedures, regulations, and industry expectations. 

This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.  

Job Responsibilities and Duties include, but are not limited to, the following: 

• Review executed batch production records for completeness, GDP and ALCOA requirements
• Communicate and resolve discrepancies with third-party CMOs
• Perform release of all manufactured, packaged and tested materials (including but not limited to raw materials, intermediates and drug products)
• Ensure timely escalation to management of all applicable incidents
• Review test and stability data ensuring data accuracy, conformance to test procedures, specifications, and documentation standards
• Initiate and track quality events (deviations, change controls, CAPAs) in Axsome’s eQMS through closure
• Work collaboratively with internal departments to respond to and resolve deviations and OOSs
• Provide support in the review and approval of cGMP-controlled documents such as master batch records, test methods, and specifications
• Provide support in the review of change controls related to manufacturing, analytical test methods, and specifications to meet cGMP and internal standards
• Support the annual product review process
• Provide QA support for process validations including reviewing protocols and reports
• Contribute to the refinement and ongoing improvement of manufacturing processes and documentation at various CMO locations
• Write and review Standard Operating Procedures, as needed
• Support the development, implementation, and improvement of corporate quality management systems that support late phase clinical and commercial programs.
• Support regulatory agency inspections as needed
• Support regulatory agency inspections as needed 
• Support the development and reporting of site Quality Metrics 

Requirements / Qualifications 

• BS degree in a scientific discipline strongly preferred
• …