Senior Specialist, Quality Assurance, Commercial Manufacturing

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.

This position will provide supporting quality oversight of Denali's clinical and commercial manufacturing and laboratory networks. This role will also contribute to developing processes and procedures for Quality Assurance.

Key Accountabilities/Core Job Responsibilities:

• Supports commercial and clinical GMP quality operations, internally and externally, including quality documentation reviews and approvals, from Manufacturing and Quality Control, such as batch records, change controls and disposition of Denali products
• Supports CMC technical operations including review, approval, and release of commercial packaging and labeling activities and commercial finished goods.
• Supports investigation and closing of OOS, OOT, and/or deviations
• Supports product quality aspects of the supply chain - commercial storage and distribution at respective 3PLs networks
• Writes and implements changes to controlled documents (SOPs, Work Instructions, Specifications, etc.) as needed
• Supports improvements in quality processes and systems and tracking/reporting of departmental metrics
• Supports quality review of IND/IMPD/BLA

Qualifications/Skills:

• BS in a related scientific discipline
• 5+ years of GMP experience in the Pharmaceutical industry
• Experience with internal and external manufacturing (CMOs), CMC development with focus on large molecules
• Experience of GMP Quality Compliance.
• Current and strong working knowledge of 21 CFR 210-211, Part 11, 610 & 820 cGMP/GLPs; EU cGMP/GLPs; and ICH quality and development guidelines.
• Able to travel domestically and internationally.

Salary Range: $113,000.00 to $135,667.00 . 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.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.