MANAGER, QUALITY ASSURANCE

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.

Responsibilities (include but are not limited to the following)

• Support implementation and execution of Quality Management System (QMS) processes including change control, deviation and CAPA
• Support the development and implementation of standard operating procedures, policies and work instructions for processes throughout the facility
• Support 'on-floor' operations such as line clearances and investigations
• Document and report product or service-related quality events
• Support the development of raw material chemical and consumable standards for inspection
• Review data and approve as required
• Review documentation for product disposition including, inventory verifications, batch record review, investigations, change control, laboratory reports, validation protocols and reports, calibration documentation and batch summary reports
• Provide disposition recommendations and decisions as required
• Work with accuracy, urgency and a continuous improvement perspective

Requirements

• 10 or more years of Biotech Manufacturing / Quality
• BS in core scientific discipline
• Familiarity with large molecule drug substance manufacturing
• Knowledge of current USP / Ph. Eur. / FDA / ISO / GMP standards and guidance
• Ability to work independently or in team environments under deadlines
• Excellent verbal and written communication skills
• Ability to closely follow quality standards and company quality expectations
• Strong collaboration and influencing skills
• Strategic thinking combined with excellence in execution
• Ability to learn quickly, driven by high curiosity

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.

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