QA Operations Manager – GMP Compliance & Supplier Oversight

Axsome Therapeutics, Inc.; New York (NY); On-site; USD 125,000 - 140,000; Full time

Benefits offered by this job

Annual bonus

Equity and benefits package

Generous benefits

Job summary

Axsome Therapeutics, Inc. is seeking a Manager/Senior Manager, QA Operations, to ensure GMP compliance across development, manufacturing, testing, shipment and distribution. The role requires on-site presence at the New York HQ for at least three days per week, with travel up to 20%.

You will lead QA operations, review cGMP documents, drive continuous improvement, and act as a liaison with CDMOs and regulatory agencies to ensure quality and regulatory readiness.

Qualifications

• Bachelor of science degree in a scientific discipline is highly preferred.
• At least 6 years in pharmaceutical QA with 3+ years of QA management/oversight of contract operations.
• Ability to travel up to 20% domestically and internationally.
• On-site work requirement: Monday, Tuesday & Thursday only; no fully remote roles.

Responsibilities

• Assist with development and implementation of quality management systems for clinical-stage R&D and commercial programs.
• Collaborate with Quality Systems & Compliance to drive continuous improvement.
• Develop KPIs to measure CMOs' operational performance and drive data-driven decisions.
• Oversee QA Operations: review/approve cGMP documentation (SOPs, batch records, validation protocols, etc.) and resolve discrepancies.
• Identify compliance issues to keep Axsome’s QMS inspection-ready.
• Serve as QA liaison between Axsome and suppliers; escalate CMO quality issues as needed.
• Alert senior management to significant quality, compliance, and supply risks.
• Collaborate with internal and external partners to address quality issues and implement corrective actions.
• Develop/revise SOPs and work instructions; maintain controlled documents.
• Build and mentor an effective Operations team with communication and performance feedback.
• Participate in vendor audits and site visits as required.

Skills

QA management

CDMOs engagement

GMP compliance

Documentation review

Audits & CAPA

Quality management systems

Cross-functional collaboration

Investigations

Regulatory knowledge

Attention to detail

Negotiation & communication

Education

Bachelor of science (scientific discipline)

Tools

ISO standards

Job description

Axsome Therapeutics, Inc. is seeking a Manager/Senior Manager, QA Operations, to ensure GMP compliance across development, manufacturing, testing, shipment and distribution. The role requires on-site presence at the New York HQ for at least three days per week, with travel up to 20%.

You will lead QA operations, review cGMP documents, drive continuous improvement, and act as a liaison with CDMOs and regulatory agencies to ensure quality and regulatory readiness.