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Salary: USD 165,000 - 180,000 / annual
Alto Neuroscience is seeking an experienced Senior Manager, CMC Quality Assurance to provide quality oversight for Chemistry, Manufacturing, and Controls (CMC) and Clinical Supplies activities. The role is critical as Alto transitions from clinical-stage to commercial-readiness manufacturing, ensuring GMP compliance and inspection readiness across drug substances, drug products, and packaged products.
Key Responsibilities:
Quality Oversight: Manage QA oversight of GMP manufacturing vendors, including review of method validation documentation, stability protocols and reports, GMP specifications, master/executed batch records, and drug substance/product release. Manage QA oversight of GMP Clinical Supply vendors, including batch record reviews and Clinical Supply release. Attend vendor meetings and provide quality feedback. Provide quality input to CMC Operations for vendor-initiated change controls, deviations, and CAPA processes. Lead or support GMP audits of manufacturing, testing partners, and Clinical Supply/Depot vendors. Prepare GMP metric reports and trending analysis for VP of Quality for periodic Management Reviews. Maintain ALTO Controlled Documents specific to CMC Quality activities.
Cross-Functional CMC Support: Partner closely with CMC Operations, Clinical Supplies, Regulatory Affairs, Clinical Operations, and other Quality organization members to support compliant program execution. Collaborate on batch record review, specification setting, stability program oversight, and vendor management.
Systems Build: Provide insight into quality systems and documentation practices appropriately scaled for a company transitioning from clinical-stage to commercial-readiness manufacturing.
Travel: Periodic travel to CDMO/Clinical Packaging sites and home office for company-wide meetings.
Requirements:
For Senior Manager level (6–9 years experience):
- 6–9 years of CMC quality experience with meaningful CMO oversight exposure
- Strong working knowledge of FDA GMP requirements and change control/deviation/CAPA systems
- Experienced in conducting GMP and Clinical Supply vendor site audits
- B.S. in a scientific discipline (chemistry, biochemistry, biology, life sciences)
Bonus skills:
- Experience with oral solid dose CNS products
- Knowledge of various packaging designs
- Experience preparing for or supporting a pre-approval inspection (PAI)
