Senior Manager, CMC Quality — Hybrid/Remote Ready

Alto Neuroscience, Inc.; Mountain View (CA); Hybrid; CAD 233,000 - 340,000; Full time

Job summary

Alto Neuroscience, Inc. is seeking a Director/Senior Manager, CMC Quality to oversee quality for GMP manufacturing and Clinical Supply activities across drug substances and products.

You will ensure compliance, readiness for inspections, and collaboration with cross-functional teams as programs progress toward registrational and commercial manufacturing. The role requires extensive CMC quality experience, vendor oversight capability, and knowledge of FDA GMP standards.

Qualifications

• 10+ years of CMC quality experience in biotech/pharma.
• Experience supporting late-stage (Phase 3) or commercial-track CMC quality programs.
• Strong working knowledge of FDA GMP requirements and change control/deviation/CAPA systems.
• Experienced in conducting GMP and Clinical Supply vendor site audits.

Responsibilities

• Provide QA oversight of GMP manufacturing vendors and related documents.
• Oversee GMP Clinical Supply vendors and release processes.
• Attend vendor meetings and provide quality feedback.
• Lead or support GMP audits of partners and Clinical Supply vendors.
• Prepare GMP metric reports and trending analyses for Management Reviews.
• Maintain ALTO controlled documents for CMC activities.
• Support cross-functional program execution with regulatory and operations.

Skills

CMC quality oversight

FDA GMP knowledge

Vendor audits

CMO/CDMO oversight

Late-stage CMC

Quality systems

Education

B.S. Life sciences

Job description

Alto Neuroscience, Inc. is seeking a Director/Senior Manager, CMC Quality to oversee quality for GMP manufacturing and Clinical Supply activities across drug substances and products.

You will ensure compliance, readiness for inspections, and collaboration with cross-functional teams as programs progress toward registrational and commercial manufacturing. The role requires extensive CMC quality experience, vendor oversight capability, and knowledge of FDA GMP standards.