Associate Director, QC for QA, CMC Quality

Denali Therapeutics

Denali Therapeutics

Quality Assurance
South San Francisco, CA, USA
Posted on Friday, August 18, 2023

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degenerative biology and the principles of translational medicine.

The Associate Director QC for QA will report to the Executive Director, Quality and will provide Quality oversight of Denali’s external manufacturing and laboratory network (CMO/CLOs), support internal/external CMC development activities, release of clinical and commercial material and audits. This role will also contribute to establishing the growth and development of the Quality organization to include, developing quality processes and documentation, and supporting implementation of an Electronic Document Management System (EDMS) and quality modules.

Responsibilities (include but are not limited to the following)

  • Provide Analytical and QC Subject Matter Expertise within the Quality Group
  • Oversee GMP Quality operations at CMOs, with a focus on QC activities, including quality documentation reviews and approvals and assisting the disposition of Denali products
  • Support PPQ activities which will include review of process validation protocols/reports, risk assessments, method validation protocols and all associated reports
  • Write Quality documentation including specifications, SOPs and Policies
  • 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 and seek continued improvement
  • Support CMC development including review and approval of QC specific documentation including CofA’s, specifications, stability studies, method validation, test methods, process validation and all associated QC data
  • Support efforts to implement and utilize the internal electronic document management system
  • Support and review relevant sections of IND/IMPD/BLA/NDA

Requirements

  • Minimum of 7 years of QC GMP experience in the Biotech/Pharmaceutical industry
  • BS degree in a scientific discipline is required and a post graduate degree is a plus
  • Experience with CMOs, CMC development with focus on both large and small molecules
  • Experience of releasing or supporting release of clinical or commercial drug substance & drug product
  • Current and strong working knowledge of 21 CFR Parts 210-211 and 11; EU cGMP/GLPs; and ICH quality and development guidelines
  • Current and strong working knowledge of Out of Specification (OOS) Investigations
  • Driven, results-oriented self-starter and excellent team player
  • Creative and pragmatic approach to problem solving and issue resolution
  • Able to travel domestically and internationally

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.

Salary Range: $162,000.00 to $192,333.00. 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.

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