Senior Director, External Quality Operations

Denali Therapeutics•South San Francisco, CA

11d•$229,000 - $297,000

About The Position

Denali Therapeutics is a biotechnology company developing biotherapeutics intended to cross the blood-brain barrier using its TransportVehicle™ platform. The Senior Director, External Quality Operations provides quality oversight of Denali’s external manufacturing network, including contract manufacturing organizations (CMOs), and supports batch release, investigations, change management, and documentation for outsourced project activities. The role oversees clinical and commercial GMP and GLP quality operations and product quality across the supply chain, from GLP toxicology batches through commercial release. It is also responsible for batch disposition across the clinical and commercial portfolio, supporting CMC development and commercial operations, and providing quality expertise for regulatory inspections. The position leads direct reports through goal setting, development planning, training compliance, and ongoing feedback.

Requirements

Typically requires a bachelor's degree in a scientific discipline; a master's degree is preferred.
12+ years of GMP experience in the pharmaceutical industry.
10+ years of coaching, mentoring, and direct people-management experience.
Current and strong working knowledge of 21 CFR 210–211, Part 11, 610, and 820 cGMP/GLPs; EU cGMP/GLPs; and ICH quality and development guidelines.
Ability to travel domestically and internationally.

Nice To Haves

A professional certification in quality, compliance, and/or regulatory affairs.
Experience with CMOs and CMC development.
Large-molecule and commercialization experience.
Experience with electronic QMS/LMS platforms such as Veeva, MasterControl, ComplianceWire, or equivalent.

Responsibilities

Oversee clinical and commercial GMP and GLP quality operations at CMOs, including review and approval of manufacturing and quality control documentation such as batch records, change controls, and product specifications.
Oversee end-to-end product quality management across supply chains and distribution networks, from GLP toxicology batches through commercial release.
Account for batch release disposition across the clinical and commercial product portfolio.
Support CMC development, including review and approval of specifications, stability studies, method validation, QC test methods, process validation, and material distribution activities.
Support CMC commercial operations by establishing infrastructure, SOPs, and execution for product launch activities.
Write and approve SOPs and policies related to compliance and quality.
Provide quality expertise for regulatory inspections, inspection-readiness activities, and responses to regulatory observations.
Lead direct reports through annual goal setting, growth planning, adherence to company policies, training compliance, and ongoing feedback on development and areas for improvement.