Senior Director, Quality

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

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

The Opportunity

Reporting to the Denali Head of QA/QC, the Sr. Director, Quality will be a member of the site leadership team, and a successful hands-on contributor to the build and start-up of Denali’s Utah manufacturing site. This individual will build and lead a quality and execution team to deliver Denali’s rapidly expanding large molecule pipeline. The Sr. Director, Quality will foster an environment that encourages Denali’s Core Values, innovation, and continuous improvement.

Responsibilities

• Oversee GMP/GLP Quality operations in Utah including quality control laboratories/testing, batch record reviews and release, environmental monitoring, and external testing laboratories.
• Responsible for building, supervising, developing, promoting, hiring and training for the GxP QC and QA team.
• Implement quality systems including document control, change management, deviations, CAPAs, audits and compliance initiatives.
• Validate computer systems such as LIMS, MasterControl and Empower.
• Support GMP site qualification including review and approval of SOPs, work instructions, specifications, stability studies, method validations, test methods, and utility and equipment/room qualifications.
• Procurement and qualification of QC instrumentation.
• Establish site quality metrics and KPIs and report to global Quality System Management Review Team.
• Represent Quality on the Utah Site Leadership Team and Denali Quality Leadership Team.

Requirements

• Education: PhD with 10 years of experience in biotech, pharma or medical device industries or a Bachelor’s degree with 15 years of experience
• Ability to travel up to 20%

Desired Knowledge/Skills/Competencies

• Significant experience in the quality support of regulated biotech, pharma or medical device manufacturing, including quality control testing through quality batch disposition.
• Understanding and familiarity with CMC development of protein therapeutics.
• Direct knowledge of FDA and EMA cGMP regulations/requirements.
• Demonstrated experience building and leading teams and developing people.
• Demonstrated ability to build trustful and effective relationships.
• Confidence to lead through uncertainty in a rapidly changing environment.
• Strong self-awareness of the impact communication and working style has on others.
• Understands that authenticity and humility at work are the keys to building trust.
• Exceptional influencing, partnership, and collaboration skills across all levels.
• Excellent oral presentation and written communication skills

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.