Director, CMC Quality

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.