Senior Director, Global Quality & Compliance

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 229,000 - 297,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics Inc. is advancing a portfolio of biotherapeutics designed to cross the blood-brain barrier. The role oversees GMP and GLP quality operations at CMOs, ensuring batch release disposition and product quality across clinical and commercial products.

The candidate will support CMC development, establish quality infrastructure, write SOPs, and provide regulatory inspection readiness, with significant leadership of a quality team and travel as needed.

Qualifications

• BS in a scientific discipline, MS preferred.
• 12+ years of GMP experience in the pharmaceutical industry.
• 10+ years of coaching, mentoring and direct people management.
• Professional certification in quality/compliance/regulatory is a plus.
• Experience with CMOs and CMC development.

Responsibilities

• Oversee GMP and GLP quality operations at CMOs, including documentation reviews and approvals.
• Oversee end-to-end product quality management across supply chain and distribution.
• Accountable for batch release disposition across clinical and commercial products.
• Support CMC development and commercial operations including SOPs and infrastructure.
• Provide quality expertise for regulatory inspections and responses.

Skills

GMP experience

People management

Quality systems

Regulatory knowledge

Travel willingness

Education

Bachelor's degree in a scientific discipline

MS degree preferred

Tools

Veeva

Master Control

ComplianceWire

Job description

Denali Therapeutics Inc. is advancing a portfolio of biotherapeutics designed to cross the blood-brain barrier. The role oversees GMP and GLP quality operations at CMOs, ensuring batch release disposition and product quality across clinical and commercial products.

The candidate will support CMC development, establish quality infrastructure, write SOPs, and provide regulatory inspection readiness, with significant leadership of a quality team and travel as needed.