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About the Role
Axsome Therapeutics is seeking a Manager/Senior Manager, QA Operations, to ensure compliance with Good Manufacturing Practices (GMP). This role will enhance quality processes and provide QA oversight of suppliers for development, manufacturing, testing, shipment, and distribution of API and finished products, ensuring adherence to company procedures and regulatory requirements.
Responsibilities
- Assist with development and/or implementation of corporate quality management systems supporting 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.
- Alert 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 external partners, including suppliers, vendors, and regulatory agencies, to ensure that our products and services meet all quality requirements.
- Develop, review or revise Standard Operating Procedures (SOPs), Work Instructions (WI) and other controlled documents.
- Builds and maintains a robust Operations team by providing effective communication, motivation, mentorship and performance feedback.
- Participate in vendor audits and site visits, as needed.
Requirements
- Bachelor of science degree highly preferred, preferably in a scientific discipline.
- At least 6 years of experience working in a pharmaceutical QA function with 3+ years of QA management/oversight of contract operations.
- Up to 20% domestic and international travel may be required.
- Ability to work on site Monday, Tuesday & Thursday.
Skills
- 1+ years managing/supervising a QA team is preferred.
- Experience working with CDMOs and relationship management preferred.
- 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.
- Comfortable multi-tasking in a fast-paced small company environment and able to navigate through ambiguity and rapid growth and adapt to change.
- Proven track record of success in developing and implementing quality policies and procedures, conducting audits and leading cross-functional teams.
Location
- New York City
Work Type
- On-site (at least three days per week)
Experience Level
- Manager/Senior Manager
Education Level
- Bachelor of Science
Salary/Compensations
- $125,000 - $140,000
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.
- 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, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates 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.
Equal Opportunity
- Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities.
- We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.