Senior Specialist, Quality Assurance Systems

Denali Therapeutics; South San Francisco (CA); On-site; USD 98,000 - 127,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics in South San Francisco is seeking a Quality Assurance Specialist to support supplier qualification, audits of CDMOs/CTLs, and internal Quality Systems. You will help maintain cGMP compliance and drive improvements across document control, deviations, CAPAs, and change controls.

The role requires 5+ years of cGMP QA experience, strong knowledge of 21 CFR parts 210-211 and ICH guidelines, and collaboration with regulatory bodies when needed. A competitive package is offered.

Qualifications

• BS in a scientific discipline with 5+ years of cGMP QA experience.
• Strong knowledge of 21 CFR 210-211, EU cGMP/GLPs, and ICH guidelines.
• Experience with electronic Quality Management Systems.
• Detail-oriented, collaborative team player with strong communication.

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.).
• 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.

Skills

cGMP Expertise

Quality Assurance

Audits

Documentation

Communication

Problem Solving

Education

Bachelor's degree in a scientific discipline

Tools

QMS Software

Job description

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.

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.

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.