Denali Therapeutics Inc. Associate Director Quality Assurance – Small Molecule Technical Quality Salary in the United States

Associate Director Quality Assurance – Small Molecule Technical Quality 

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

The Opportunity

Reporting to the Senior Director and Head of GMP and GLP Quality Assurance and Quality Control, the Associate Director of QA will provide quality oversight of Denali’s external manufacturing and laboratory network (CMO/CLOs) and support internal/external CMC development activities. This role will also contribute to establishing the internal quality framework including developing quality documentation and implementation of an electronic document management system (EDMS) and quality modules.

Responsibilities (include but are not limited to the following)

• Oversee GMP and GLP quality operations at CMOs, including quality documentation reviews and approvals such as batch records and specifications, disposition of Denali products and audits as needed.
• Write SOPs and Policies related to compliance and quality.
• Oversee product quality aspects of the supply chain and distribution networks.
• Establish and support quality systems and operations, including document control, deviation reporting and temperature excursions.
• Support CMC development including review and approval of specifications, stability studies, method validation, QC test methods, process validation and material distribution activities.
• Support efforts to implement and utilize the internal electronic document management system.
• Serve as a back-up to the other technical quality team members to support the CMC and Supplier teams.

Requirements

• 10-15 years of GMP experience in the Pharmaceutical industry.
• MS or BS in a scientific discipline and professional certification in quality, compliance and/or regulatory is a plus.
• Experience with CMOs, CMC development with focus on small molecules and large molecule experience is a plus.
• Current and strong working knowledge of 21CFR 210-211, Part 11, & 820 cGMP/GLPs; EU cGMP/GLPs; and ICH quality and development guidelines.
• Familiarity with electronic document management systems.
• Driven, results-oriented self-starter and excellent team player.
• Creative and pragmatic approach to problem solving and issue resolution.
• Able to travel domestically and internationally.

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