Specialist, Quality Assurance

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

About This Role 

Axsome Therapeutics is seeking a Specialist, Quality Assurance to focus on ensuring compliance with Good Manufacturing Practices (GMP) with all work performed. The Specialist, Quality Assurance 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
• Prov