Senior Specialist, Quality Assurance Systems
Denali Therapeutics
Summary
The Quality Assurance Specialist will provide support for supplier qualification (CDMO/CLOs), and process improvement activities. This role will also support Denali Quality Systems.
Job description
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
Requirements
- BS in a scientific discipline
- 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 knowledge
- ICH Quality and development guidelines knowledge
- 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
- Strong attention to detail
- Ability to closely follow Quality Standards and company Quality expectations
Benefits
- 401(k)
- Healthcare coverage
- ESPP
Company overview
Denali Therapeutics is a pioneering biotechnology company focused on developing innovative therapeutics for neurodegenerative and lysosomal storage diseases. Founded in 2015 and headquartered in South San Francisco, California, the company has developed a proprietary TransportVehicle™ (TV) platform designed to enable biotherapeutics to cross the blood-brain barrier, addressing one of the most significant challenges in treating central nervous system disorders. Denali's pipeline includes promising candidates for conditions such as Hunter syndrome (MPS II), Parkinson's disease, frontotemporal dementia, Sanfilippo syndrome (MPS IIIA), and MPS I, with several programs in advanced clinical development stages. The company collaborates with major pharmaceutical partners including Biogen and Sanofi, leveraging its platform technology to create a new class of barrier-crossing therapeutics. With approximately 500-1,000 employees and operations spanning multiple locations including Salt Lake City, Denali Therapeutics represents a leading force in neuroscience drug development, combining deep scientific expertise with a patient-centric approach to transform treatment paradigms for serious neurological conditions.