Director, Quality
Denali Therapeutics
June 25, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
Key Accountabilities / Core Job Responsibilities:
- Oversee GMP and GLP quality operations at CMOs, including quality documentation reviews/approvals (batch records, change controls, specifications), disposition of Denali products, and audits as needed.
- Oversee product quality aspects of the supply chain and distribution networks (from GLP tox batches to commercial release).
- Establish/support quality systems and operations, including document control, deviation reporting, and temperature excursions.
- Support CMC development: review/approval of specifications, stability studies, method validation, QC test methods, process validation, and material distribution.
- Support CMC commercial operations: establish infrastructure and SOPs for Product Launch execution.
- Implement and utilize the QMS through internal electronic document management system and associated eQMS modules.
- Write and approve SOPs and policies related to compliance and quality.
- Represent Quality on cross-functional working groups/projects; ensure execution aligns with regulatory guidance.
- Back-up technical quality team members to support CMC and Supplier teams.
- Lead direct reports (goal setting, growth planning, training compliance, ongoing feedback).
Qualifications / Skills:
- BS in a scientific discipline; MS preferred; professional certification in quality/compliance/regulatory is a plus.
- 10+ years GMP experience (pharmaceutical industry).
- 8+ years management experience.
- Experience with CMOs and CMC development; large molecule or commercialization experience is a plus.
- Strong working knowledge of 21 CFR 210-211, Part 11, 610 & 820; EU cGMP/GLPs; ICH quality/development guidelines.
- Familiarity with eQMS systems.
- Ability to travel domestically and internationally.
Benefits (if stated): 401k, healthcare coverage, ESPP, and other benefits.
Application instructions: Learn more at https://www.denalitherapeutics.com/careers
- Oversee GMP and GLP quality operations at CMOs, including quality documentation reviews/approvals (batch records, change controls, specifications), disposition of Denali products, and audits as needed.
- Oversee product quality aspects of the supply chain and distribution networks (from GLP tox batches to commercial release).
- Establish/support quality systems and operations, including document control, deviation reporting, and temperature excursions.
- Support CMC development: review/approval of specifications, stability studies, method validation, QC test methods, process validation, and material distribution.
- Support CMC commercial operations: establish infrastructure and SOPs for Product Launch execution.
- Implement and utilize the QMS through internal electronic document management system and associated eQMS modules.
- Write and approve SOPs and policies related to compliance and quality.
- Represent Quality on cross-functional working groups/projects; ensure execution aligns with regulatory guidance.
- Back-up technical quality team members to support CMC and Supplier teams.
- Lead direct reports (goal setting, growth planning, training compliance, ongoing feedback).
Qualifications / Skills:
- BS in a scientific discipline; MS preferred; professional certification in quality/compliance/regulatory is a plus.
- 10+ years GMP experience (pharmaceutical industry).
- 8+ years management experience.
- Experience with CMOs and CMC development; large molecule or commercialization experience is a plus.
- Strong working knowledge of 21 CFR 210-211, Part 11, 610 & 820; EU cGMP/GLPs; ICH quality/development guidelines.
- Familiarity with eQMS systems.
- Ability to travel domestically and internationally.
Benefits (if stated): 401k, healthcare coverage, ESPP, and other benefits.
Application instructions: Learn more at https://www.denalitherapeutics.com/careers