Senior Director, Global Quality & CMO Oversight

Denali Therapeutics

South San Francisco (CA)

On-site

USD 229,000 - 297,000

Full time

12 days ago

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics Inc. is seeking a senior quality leader to oversee the company’s external manufacturing network (CMOs) and ensure compliant batch release across clinical and commercial programs.

The role focuses on GMP/GLP oversight, documentation reviews, and continuous quality improvement in a fast-paced biotech environment. Based in South San Francisco, this on-site position requires extensive regulatory knowledge, cross-functional collaboration, and leadership to advance Denali’s

Qualifications

BS in a scientific discipline with 12+ years of GMP experience in pharma.
MS degree is preferred.
Coaching, mentoring and direct people management experience (10+ years).
Experience with CMOs and CMC development a plus.
Strong knowledge of 21 CFR 210-211, Part 11, 820 and ICH guidelines; travel willingness.

Responsibilities

Oversee clinical and commercial GMP/GLP quality ops at CMOs and review technical documentation.
Manage end-to-end product quality across supply chain and distribution networks.
Accountable for batch release disposition for clinical and commercial products.
Support CMC development and commercial operations, including specs, stability, validation.
Draft and approve SOPs/Policies; prepare for regulatory inspections; lead team growth.