Senior Specialist, Quality Assurance Systems
About the role
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. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The Quality Assurance Specialist will provide support for supplier qualification (CDMO/CLOs), and process improvement activities. This role will also support Denali Quality Systems.
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/NDAS
- Supports and participates in regulatory body inspection readiness
- May interface with regulatory agencies as required.
Qualifications
- 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.
Skills
- 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 Den