What are the responsibilities and job description for the Director, Quality (QA/QC) position at Denali Therapeutics?
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 quality oversight of Denali’s external manufacturing and laboratory network (CMO/CLOs) and support internal/external CMC development activities. This position will also contribute to establishing the internal quality framework including developing quality documentation and will represent Quality cross functionally within Denali for given project activities.
Key Accountabilities/Core Job Responsibilities
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.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
This position will provide quality oversight of Denali’s external manufacturing and laboratory network (CMO/CLOs) and support internal/external CMC development activities. This position will also contribute to establishing the internal quality framework including developing quality documentation and will represent Quality cross functionally within Denali for given project activities.
Key Accountabilities/Core Job Responsibilities
- Oversee GMP and GLP quality operations at CMOs, including quality documentation reviews and approvals, from Manufacturing and Quality Control, such as batch records, change controls and specifications, disposition of Denali products and audits as needed.
- Oversee product quality aspects of the supply chain and distribution networks from GLP tox batches to Commercial release.
- Establish and support quality systems and operations, including document control, deviation reporting and temperature excursions.
- Support CMC development including review and approval of specifications, stability studies, method validation, QC test methods, process validation and material distribution activities.
- Support CMC commercial operations including establishing infrastructure, SOPs and execution for Product Launch activities.
- Support efforts to implement and utilize the QMS through the internal electronic document management system and associated eQMS modules.
- Write and approve SOPs and Policies related to compliance and quality.
- Represent Quality on cross functional working groups and projects as required, ensuring the provision of program execution consistent with all regulatory guidance.
- Serve as a back-up to the other technical quality team members to support the CMC and Supplier teams and leadership as required.
- Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.
- BS in a scientific discipline; MS preferred; professional certification in quality, compliance and/or regulatory is a plus
- 10 years of GMP experience in the Pharmaceutical industry.
- 8 years of management experience
- Experience with CMOs, and CMC development. Large molecule or commercialization experience is a plus.
- 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.
- Familiarity with eQMS systems.
- 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.
Salary : $192,000 - $249,000