Senior/Director, CMC Quality — Biotech (Hybrid)

Alto Neuroscience; Mountain View (CA); Hybrid; USD 165,000 - 240,000; Full time

Job summary

Alto Neuroscience, Inc. in Mountain View, CA, seeks a Director/Senior Manager, CMC Quality to provide quality oversight for GMP manufacturing and clinical supplies across drug substances and products, ensuring readiness for registrational and commercial manufacturing.

You will lead QA oversight of vendors, manage change control, deviations, CAPA, and GMP audits, and collaborate with Regulatory, CMC Operations, and Clinical Supplies to scale quality systems for a transition from clinical to

Qualifications

• 10+ years of CMC quality experience in biotech/pharma.
• Experience with late-stage (Ph0/3) or commercial-track CMC quality programs.
• Strong working knowledge of FDA GMP requirements and change control/deviation/CAPA systems.

Responsibilities

• Provide QA oversight of GMP manufacturing vendors and clinical supply vendors, including records and release reviews.
• Lead or support GMP audits of manufacturing/testing partners and Clinical Supply vendors.
• Prepare GMP metric reports and assist in Management Reviews.

Skills

CMC quality oversight

GMP knowledge

Vendor management

Audit experience

Education

B.S. in a scientific discipline

Tools

CAPA systems

Change control systems

Job description

Alto Neuroscience, Inc. in Mountain View, CA, seeks a Director/Senior Manager, CMC Quality to provide quality oversight for GMP manufacturing and clinical supplies across drug substances and products, ensuring readiness for registrational and commercial manufacturing.

You will lead QA oversight of vendors, manage change control, deviations, CAPA, and GMP audits, and collaborate with Regulatory, CMC Operations, and Clinical Supplies to scale quality systems for a transition from clinical to