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.

We are seeking a detail-oriented and experienced Senior QA Specialist to support biologics manufacturing operations. The QA Specialist will play a key role in ensuring compliance with cGMP standards, internal procedures, and regulatory requirements.

Key Accountabilities/Core Job Responsibilities:

• Provide on-the-floor QA support for manufacturing operations across all production areas.
• Perform electronic batch record review and QA approval of in-process and finished product documentation.
• Review GMP documentation for product disposition including, inventory verifications, batch records, investigations, change control, laboratory reports, validation protocols and reports, calibration and maintenance documentation and batch summary reports
• Support internal and external audits
• Support environmental monitoring investigations and aseptic process assessments
• Support root cause analysis and corrective/preventive actions for complex quality events
• Collaborate cross-functionally-including Process Dev, QC, Manufacturing, and Validation-to support scale-up, tech transfer, and inspection readiness
• Support raw material and lot release activities and quality system updates as needed
• Represent Quality for technology transfers and new product introductions
• Work with accuracy, urgency and a continuous improvement perspective

Qualifications/Skills:

• Bachelor's degree in life science, biology, biotechnology, or a related scientific discipline.
• 5+ years of experience in QA or QC within a biologics or pharmaceutical manufacturing environment.
• Previous experience working in a GMP regulated facility
• Familiarity with large molecule drug substance manufacturing, cleanroom practices, and microbiological testing methods.
• In depth understanding of cGMP, FDA, and EU regulatory requirements.
• Excellent communication, documentation, and organizational skills.
• Ability to make key quality decisions on the floor
• Ability to work independently and collaborate effectively with cross-functional teams.
• Familiar with Master Control, LIMS and Kneat applications

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.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.