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About the Role
The Quality Assurance Specialist will support supplier qualification, process improvement activities, and Denali Quality Systems. This role is crucial in advancing Denali's goal of delivering effective medicines to patients with serious diseases.
Responsibilities
- Support supplier qualification and conduct quality audits for Denali sites including CDMOs/CTLs
- Support tracking/reporting departmental metrics for Quality Systems Management Reviews
- Support Quality Systems and Operations, including document control, change controls, deviations, CAPAs, effectiveness checks and temperature excursions
- Write changes to controlled documents (SOPs, Work Instructions, Specifications, etc.) as needed
- Ensure compliance to cGMPs per regulations
- Make improvements in Quality processes and systems
- Support efforts to implement and utilize the internal electronic document management system
- Support Quality review of IND/IMPD/BLA/NDA
- Support and participate in regulatory body inspection readiness
- May interface with regulatory agencies as required
Requirements
- 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
Skills
- cGMP experience
- Pharmaceutical Quality Assurance
- 21 CFR Parts 210-211 and 11
- EU cGMP/GLPs
- ICH Quality and development guidelines
- Electronic Quality Management Systems
- Communication skills
- Problem solving
- Attention to detail
Experience Level
- 5+ years of cGMP experience
Education Level
- BS in a scientific discipline
Salary/Compensations
- $98,000.00 to $127,000.00
Benefits
- 401k
- Healthcare coverage
- ESPP
About the Company
- Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform.
- With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.
Equal Opportunity
- 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.