BS in a scientific discipline with 5+ years of cGMP experience in Pharmaceutical Quality Assurance
Strong knowledge of 21 CFR Parts 210-211 and 11; EU cGMP/GLPs; and ICH Quality 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 problem solver
Strong attention to detail
Ability to adhere to Quality Standards and company expectations
Commitment to Denali's values of growth, unity, grit, and trust
Responsibilities
Support supplier qualification and conduct quality audits for Denali sites including CDMOs/CTLs
Track and report departmental metrics for Quality Systems Management Reviews
Manage document control, change controls, deviations, CAPAs, effectiveness checks, and temperature excursions
Write changes to controlled documents (SOPs, Work Instructions, Specifications) as needed
Ensure compliance with cGMP regulations
Improve Quality processes and systems
Implement and utilize the internal electronic document management system
Support Quality review of IND/IMPD/BLA/NDA
Participate in regulatory body inspection readiness and interface with regulatory agencies as required
Benefits
401k
Healthcare coverage
Employee Stock Purchase Plan (ESPP)
Broad range of other benefits
Full Job Description
The Quality Assurance Specialist will provide support for supplier qualification (CDMO/CLOs), and process improvement activities. This role will also support Denali Quality Systems.
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
Salary Range: $98,000.00 to $127,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
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.
About Denali Therapeutics
Denali Therapeutics is a biotechnology company focused on developing therapies for neurodegenerative diseases. The company's pipeline includes treatments for Parkinson's disease, Alzheimer's disease, and amyotrophic lateral sclerosis (ALS). Denali Therapeutics uses a proprietary technology platform to develop drugs that can cross the blood-brain barrier, which is a major challenge in treating neurological disorders. The company was founded by a team of scientists with extensive experience in drug development and neuroscience research.
