Manager/Senior Manager, QA Operations

The role

The Manager/Senior Manager, QA Operations ensures compliance with Good Manufacturing Practices. This person provides QA oversight of suppliers for the development, manufacturing, testing, shipment, and distribution of API and finished products.

What you will do

• Assist with development and implementation of corporate quality management systems
• Support the development of key performance indicators to measure and report CMO operational performance
• Review and approve cGMP-related documentation including SOPs, batch records, and deviations
• Identify and address compliance issues to maintain inspection readiness
• Serve as a Quality liaison between Axsome and suppliers
• Serve as an escalation point for CMO quality issues
• Alert senior management of significant quality, compliance and supply risks
• Collaborate with internal cross-functional teams to address quality issues and implement process improvements
• Collaborate with external partners to ensure products and services meet quality requirements
• Develop, review or revise SOPs, Work Instructions and other controlled documents

Required qualifications

• At least 6 years of experience working in a pharmaceutical QA function
• 3+ years of QA management/oversight of contract operations
• Strong hands-on knowledge of API and drug product (oral solids) manufacturing processes
• Strong knowledge of FDA/EEA/HC regulations, ISO and other applicable quality standards
• Strong attention to detail and excellent organization skills
• Excellent interpersonal, communication (verbal/written) and negotiation skills
• Ability to work on site Monday, Tuesday & Thursday
• Proven track record of success in developing and implementing quality policies and procedures, conducting audits and leading cross-functional teams

Nice to have

• Bachelor of science degree preferably in a scientific discipline
• 1+ years managing/supervising a QA team
• Experience working with CDMOs and relationship management

Benefits

• Annual bonus
• Significant equity
• Generous benefits package

About the company

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. Their neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia, excessive daytime sleepiness, and migraine.