What are the responsibilities and job description for the Senior Specialist, Quality Assurance Systems 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.
Key Accountabilities/ Core Job Responsibilities:
Support supplier qualification and conduct quality audits for Denali sites including CDMOs/CTLs
Supports tracking/reporting departmental metrics for Quality Systems Management Reviews
Supports Quality Systems and Operations, including document control, change controls, deviations, CAPAs, effectiveness checks and temperature excursions.
Writes changes to controlled documents (SOPs, Work Instructions, Specifications, etc.) as needed
Responsible for ensuring compliance to cGMPs per regulations
Makes improvement in Quality processes and systems
Supports efforts to implement and utilize the internal electronic document management system.
Supports Quality review of IND/IMPD/BLA/NDA
Supports and participates in regulatory body inspection readiness
May interface with regulatory agencies as required.
Qualifications/Skills:
BS in a scientific discipline with 5 years of cGMP experience in Pharmaceutical Quality Assurance
Current and strong working knowledge of 21 CFR Parts 210-211 and 11; EU cGMP/GLPs; and ICH Quality and development guidelines.
Experience with electronic Quality Management Systems.
Driven, results-oriented self-starter and excellent team player.
Excellent verbal and written communication skills.
Creative and pragmatic approach to problem solving and issue resolution.
Maintain a strong attention to detail.
Ability to closely follow Quality Standards and company Quality expectations
Committed to Denali values of growth, unity, grit, and trust; as well as values related to accountability, transparency, and scientific rigor
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.
Salary : $113,000 - $135,667
