Senior Manager, CMC Quality Assurance
About The Position
Alto Neuroscience is seeking an experienced Director/Senior Manager, CMC Quality to provide quality oversight for Chemistry, Manufacturing, and Controls (CMC) and Clinical Supplies activities across drug substances, drug products, and packaged products. The role ensures GMP compliance and inspection readiness as programs advance toward registrational and commercial manufacturing. The level will depend on the candidate’s experience. The position oversees GMP manufacturing and Clinical Supply vendors, supports CMC Operations and Clinical Supplies, and contributes to quality systems and documentation practices appropriate for a company transitioning from clinical-stage to commercial-readiness manufacturing. The preferred location is Mountain View, California, in a hybrid arrangement; remote work may be considered for the right candidate. Periodic travel to CDMO and Clinical Packaging sites and to the home office for company-wide meetings is required.
Requirements
- Director level: 10 or more years of CMC quality experience in biotech or pharma, including direct CMO/CDMO oversight.
- Director level: Experience supporting late-stage (Phase 3) or commercial-track CMC quality programs.
- Strong working knowledge of FDA GMP requirements and change control, deviation, and CAPA systems.
- Experience conducting GMP and Clinical Supply vendor site audits.
- Senior Manager level: 6–9 years of CMC quality experience with meaningful CMO oversight exposure.
- B.S. in a scientific discipline, such as chemistry, biochemistry, biology, or life sciences.
Nice To Haves
- Experience with oral solid dose CNS products.
- Knowledge of various packaging designs.
- Experience preparing for or supporting a pre-approval inspection (PAI).
Responsibilities
- Manage QA oversight of GMP manufacturing vendors, including review of method validation documentation, stability protocols and reports, GMP drug substance and drug product specifications, master and executed batch records, and product release.
- Manage QA oversight of GMP Clinical Supply vendors, including master and executed batch record reviews and Clinical Supply release.
- Attend vendor meetings with relevant functional areas and provide quality feedback.
- Provide quality input to CMC Operations regarding vendor-initiated change controls, deviations, and CAPA processes.
- Lead or support GMP audits of manufacturing and testing partners, as well as Clinical Supply and Depot vendors.
- Prepare GMP metrics reports and trending analyses for the VP of Quality for periodic Management Reviews.
- Maintain ALTO controlled documents specific to CMC Quality activities.
- Partner with CMC Operations, Clinical Supplies, Regulatory Affairs, Clinical Operations, and other Quality team members to support compliant program execution.
- Partner with CMC Operations and Clinical Supplies on batch record review, specification setting, stability program oversight, and vendor management.
- Provide input on quality systems and documentation practices scaled to the company’s transition from clinical-stage to commercial-readiness manufacturing.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
