Senior Specialist, Quality Assurance Systems

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

The Senior Specialist in Quality Assurance will provide quality oversight of Denali's external manufacturing and laboratory network (CMO/CLOs), support internal/external CMC development activities and audits. 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.

Key Accountabilities/ Core Job Responsibilities:

• Oversee GMP and GLP quality operations at CMOs, including quality documentation reviews and approvals such as batch records, specifications, disposition of Denali products.
• Write SOPs and Policies related to compliance and quality.
• Support supplier qualification and quality audits for Denali sites including CMOs/CTLs as needed
• Oversee product quality aspects of the supply chain and distribution networks.
• Establish and support quality systems and operations, including document control, change controls, deviation, CAPA, effectiveness checks and temperature excursions.
• Improve quality processes and systems
• 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.
• Support quality review of IND/IMPD/BLA

Qualifications/Skills:

• BS in a scientific discipline with 5+ years of cGMP experience in Pharmaceutical Quality Assurance
• Experience with CMOs, CMC development with focus on large molecules and small molecule experience is a plus.
• Current and strong working knowledge of 21 CFR Parts 210-211 and 11; 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.
• Ability to travel domestically and internationally up to 10%.
• Ability to closely follow Quality Standards and company Quality expectations
• Committed to Denali values of growth, unity, grit, and trust; as well as values related to accountability, transparency, and scientific rigor

Salary Range: $98,000.00 to $127,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.