Director, CMC Quality at Slate Medicines Director, CMC Quality at Slate Medicines in Raleigh, North Carolina Posted in about 15 hours ago.

Type:

full-time

•Direct applicants only. We are not working with third-party agencies. About Slate Medicines Slate Medicines is a clinical-stage biotech company developing next-generation therapeutics for migraine and other headache disorders. Its lead program, SLTE-1009, is a subcutaneous monoclonal antibody targeting both PACAP and VIP, with the potential to be a best-in-class option for migraine prevention; the program entered Phase 1 in 2026, with topline data expected in mid-2027 and a Phase 2 start planned for 2027. Slate is backed by leading healthcare investors including RA Capital Management, Forbion, Foresite Capital, and Frazier Life Sciences, and is on track to become a publicly traded company (

Nasdaq:

SLTE) through a planned merger with Fulcrum Therapeutics. The Role Slate Medicines is seeking an experienced, hands-on Director, CMC Quality to build and lead the biologics Quality function from the ground up. This is a foundational role for a quality leader who thrives in a fast-paced, resource-conscious start-up and can operate across the full spectrum of GxP quality - as both strategic architect and hands-on practitioner who reviews documents, conducts audits, and hosts inspections personally. Key Responsibilities Design, implement, and scale a phase-appropriate QMS as the pipeline advances from nonclinical through clinical development. Establish core quality infrastructure - document control, deviations/CAPA, change control, complaint handling, training, vendor qualification - and author/maintain SOPs meeting regulatory and data integrity (ALCOA+) standards. Champion a strong quality culture across all functions. Own audit programs (internal and CDMO/vendor) and inspection readiness, serving as primary host for FDA/EMA inspections and driving CAPAs to closure. Provide quality oversight of drug substance and drug product manufacturing, testing, and release, partnering with CMC/Tech Ops on tech transfer and validation. Manage vendor/CDMO quality agreements and materials release processes. Support regulatory submissions and, where applicable, device/combination product quality (design controls, risk management, DHF). Build and lead the Quality function as the company grows. Qualifications Required Bachelor's degree in a scientific/technical field; advanced degree preferred. 15+ years of progressive QA experience in biotech/pharma, including significant Director-level experience. Hands-on experience standing up a QMS from scratch, with proven biologics manufacturing oversight (CDMO, drug substance/drug product). Direct experience hosting regulatory inspections and running audit programs. Start-up experience building processes across multiple areas of responsibility. Strong GMP knowledge (GLP a plus); excellent communication, leadership, and independent judgment. Preferred Device/combination product quality systems experience (ISO 13485, ISO 14971). Experience supporting IND/BLA submissions and scaling quality through Phase 1 to registration.