Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for central nervous system (CNS) conditions that have limited treatment options$1. .$1
Biopharmaceuticals • Pain • CNS • Narcolepsy • Major Depressive Disorder
201 - 500
Manager, QA Systems
2 days ago
🏢 In-office - Manhattan
Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for central nervous system (CNS) conditions that have limited treatment options$1. .$1
Biopharmaceuticals • Pain • CNS • Narcolepsy • Major Depressive Disorder
201 - 500
Description
• Support development, implementation, and improvement of corporate quality management systems • Assist with management and development of electronic quality management systems • Develop and implement a comprehensive supplier qualification program • Conduct assessments of suppliers for regulatory adherence • Lead investigations of product quality complaints • Monitor Quality Systems via metrics • Conduct GMP audits of external CMOs and labs • Audit internal processes for SOP adherence • Serve as escalation point for quality issues • Review and approve internal change controls • Maintain inspection readiness for QMS • Author and revise SOPs, Work Instructions, and controlled documents • Follow through on corrective actions from deviations • Escalate serious compliance issues to senior management • Maintain knowledge of GxP requirements and impacts on SOPs
Requirements
• Bachelor of science degree required, preferably in a scientific discipline • At least 5 years’ experience working in QA/QC within the pharmaceutical or biotechnology industries • Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles
Benefits
• Annual bonus • Significant equity • Generous benefits package
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