CMC Quality Leader: GMP Oversight for Late-Stage Biotech

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

Job summary

Alto Neuroscience is seeking a Director/Senior Manager, CMC Quality to oversee GMP compliance for drug substances, drug products, and packaging. The role focuses on quality oversight of GMP manufacturing and Clinical Supply vendors, with audits, change control, and CAPA execution, advancing programs toward registrational and commercial manufacturing.

Hybrid Mountain View preferred, remote considered for the right candidate.

Qualifications

• 10+ years of CMC quality experience in biotech/pharma, including direct CMO/CDMO oversight.
• 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.
• 6–9 years of CMC quality experience with meaningful CMO oversight exposure.

Responsibilities

• QA oversight of GMP manufacturing vendors, including review of validation docs, stability reports, and master/issued batch records.
• QA oversight of GMP Clinical Supply vendors, including batch record reviews and releases.
• Attend vendor meetings and provide quality feedback to cross-functional teams.
• Provide quality input to CMC Operations for change controls, deviations, and CAPA processes.
• Lead or support GMP audits of manufacturing, testing partners, and Clinical Supply vendors.
• Prepare GMP metric reports and trending analyses for periodic reviews.
• Maintain ALTO controlled documents specific to CMC Quality activities.
• Travel periodically to CDMO sites and home office as needed.

Skills

CMC Quality

GMP Knowledge

Vendor Audits

Change Control

Deviation CAPA

QA Oversight

Education

BS in science

Job description

Alto Neuroscience is seeking a Director/Senior Manager, CMC Quality to oversee GMP compliance for drug substances, drug products, and packaging. The role focuses on quality oversight of GMP manufacturing and Clinical Supply vendors, with audits, change control, and CAPA execution, advancing programs toward registrational and commercial manufacturing.

Hybrid Mountain View preferred, remote considered for the right candidate.