Director, CMC Quality

Slate Medicines; Raleigh (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Slate Medicines is seeking a Director, CMC Quality to build and lead the biologics QA function from the ground up in a fast-paced startup environment. You will architect a phase-appropriate QMS and personally oversee audits, inspections, and regulatory interactions as the program advances from nonclinical to clinical stages.

The role requires 15+ years of biotech QA experience, hands-on QMS setup, and strong GMP knowledge, with a track record of regulatory inspections and cross-functional

Qualifications

• Bachelor's degree in a scientific or technical field is required; 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 and oversight of biologics manufacturing (CDMO, drug substance/product).
• Experience hosting regulatory inspections and running audit programs in a biotech/pharma setting.
• Startup experience building processes across multiple areas of responsibility; strong GMP knowledge (GLP a plus).

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.
• Champion a strong quality culture across all functions.
• Own audit programs (internal and CDMO/vendor) and inspection readiness; host FDA/EMA inspections and drive CAPAs to closure.
• Provide quality oversight of drug substance/product manufacturing, testing, and release; partner 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.

Skills

QA experience

Leadership

Regulatory inspections

GxP knowledge

Education

Bachelor's degree in a scientific/technical field

Advanced degree preferred

Tools

QMS

Job description

*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

• Experience supporting IND/BLA submissions and scaling quality through Phase 1 to registration.