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.
About This Role
Axsome Therapeutics is seeking a Manager/Senior Manager, QA Operations, responsible for ensuring compliance with Good Manufacturing Practices (GMP) with all work performed. The Manager/Senior Manager, QA Operations will contribute towards the enhancement of Axsome quality processes and ensures appropriate QA oversight of suppliers (CDMOs and GMP-related service providers) contracted for the development, manufacturing, testing, shipment and/or distribution of API and finished products to assure compliance with company procedures, FDA/EEA/Health Canada regulations and assists with tasks necessary to achieve department and/or company goals.
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:
- Assist with development and/or implementation of corporate quality management systems that support 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
- Alerts 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 / Qualifications
- 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. We are unable to consider candidates who are looking for fully remote roles
Experience, Knowledge and 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
Salary & Benefits
The anticipated salary range for this role is $125,000 - $140,000. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
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.
Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.
Skills Required
- Bachelor of Science degree, preferably in a scientific discipline
- At least 6 years of experience working in a pharmaceutical QA function
- At least 3 years of QA management or oversight of contract operations
- Availability for up to 20% domestic and international travel
- Ability to work onsite Monday, Tuesday, and Thursday in New York City
- At least 1 year of experience managing or supervising a QA team
- Experience working with CDMOs and relationship management
- Hands-on knowledge of API and oral solid drug product manufacturing processes
- Knowledge of FDA, EEA, Health Canada, ISO, and other applicable quality standards
- Experience developing and implementing quality policies and procedures
- Experience conducting audits and leading cross-functional teams
- Strong attention to detail and organizational skills
- Excellent interpersonal, communication, and negotiation skills
- Ability to multitask, navigate ambiguity, and adapt to a fast-paced environment
Axsome Therapeutics, Inc. Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Axsome Therapeutics, Inc. and has not been reviewed or approved by Axsome Therapeutics, Inc..
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Healthcare Strength — Employer contributions cover around 85% of medical, dental, and vision premiums, with multiple plan options (EPO/PPO/HDHP) plus company‑paid life, AD&D, and short‑/long‑term disability. Eligibility typically begins the first of the month after start, supporting comprehensive access.
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Equity Value & Accessibility — New hires commonly receive stock options and RSUs with potential annual grants, alongside an Employee Stock Purchase Plan at a 15% discount. Company materials and postings position equity as a significant component of total rewards.
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Leave & Time Off Breadth — PTO starts at 15 days and increases to 20 with tenure, complemented by 13 company holidays, floating and mental‑health days, sick time, and a five‑week sabbatical at five years. Paid parental leave up to 12 weeks for birthing parents (four weeks for non‑birthing) plus five days of grandparent leave expand family‑friendly time off.
Axsome Therapeutics, Inc. Insights
What We Do
Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are intensely committed to developing products that meaningfully improve the lives of patients and provide additional therapeutic options for physicians
