What are the responsibilities and job description for the Associate Director, QC for QA position at Denali Therapeutics Inc?
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)
- 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 CofAs, 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
Requirements
- Bachelor’s degree in a scientific discipline, post graduate degree is a plus.
- 7 years of AD and or QC GMP experience in the Biotech/Pharmaceutical industry.
- 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 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.
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.
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