Associate Director, Computer System Assurance

Quality Assurance (850) · Oakland, California
Department Quality Assurance (850)
Employment Type Full-Time
Minimum Experience Manager/Supervisor

Company:

Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1b trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases.

 

Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids, and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. Chinook trades on Nasdaq under the ticker symbol KDNY and has locations in Vancouver, BC, Seattle, WA and Oakland, CA.


Position:

The Associate Director Computer System Assurance is responsible for the improvement, design, development, and implementation of the GxP QMS computerized system and software management processes at Chinook. This includes, but is not limited to, Data Integrity, Computer Systems Validation (e.g. Computer System Assurance), Computer System Vendor Management, and Quality Agreements with GxP computer system and software providers. The role includes oversight of computer systems and their interaction with GxP processes, improving and maintaining GxP computerized system business processes, and implementation and release management of GxP computerized systems. This position will ensure GxP Computer Systems are validated in compliance with 21 CFR Part 11, EudraLex Vol 4, Annex 11, GAMP and applicable ICH guidance. The Associate Director of Computer System Assurance will preferably be based in one of the Chinook West coast offices (Vancouver, BC; Seattle, Washington; Oakland, CA; San Diego, CA) and will report to the Director, Quality Management Systems.

 

 Responsibilities include:

 

  • Lead the development and continuous improvement of the Computer System Assurance process at Chinook
  • QA Validation Lead for the implementation of GxP solutions:
    • Clinical Systems - eTMF, eCTMS
    • Quality Systems - eDMS, eLMS, CAPA, Audits
    • Quality Control Systems – LIMS
    • Biometrics Systems – EDC, SAS
  • Audit computer system software, SaaS and IT outsource service vendors, CMOs, and CROs as necessary
  • Provide compliance leadership, direction, and oversight in the area of Computer System Assurance and data integrity
  • Responsible for the quality assurance oversight of GxP regulated computerized systems
  • Develop and maintain computerized system life cycle documentation:  user requirement specifications (URS), functional requirement specifications (FRS), design specifications, risk analysis, traceability matrices, standard operating procedures, installation qualification protocols, operation qualification protocols, performance qualification protocols, validation master plans, user acceptance testing, and validation summary reports.
  • Responsible for ensuring data integrity of computer systems and their interactions with other systems
  • Implement risk-based approaches that focuses on a systems intended use and its impact to patient safety, product quality, and leverage approved vendor internal control, testing and automation to enhance process efficiency.
  • Improve and establish standard operating procedures for efficient and compliant management of GxP QMS processes
  • Establish and track quality metrics for computer processes and present improvement opportunities at Management Review meetings
  • Ensure compliance to regulatory expectations and ensure the Quality Management System supports inspection preparedness plans for the GxP computer system processes
  • Establish efficient and compliant release management processes for GxP computerize systems.
  • Contribute to the development and maintenance of a positive team-focused company culture


Education, Experience, and Skills:

 

  • Bachelor’s degree in an engineering, mathematical or scientific/technical discipline with a minimum of 10 years’ experience in a GxP environment or validation of IT applications, or an equivalent combination of education and experience.
  • Prior management or direct experience working with Computer Systems Validation
  • In-depth understanding of GAMP 5, 21 CFR Part 11, EudraLex Vol 4, Annex 11, ICH and current global regulatory expectations
  • Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results
  • Working knowledge of computer system lifecycle and management
  • Technical proficiency, attention to detail, creativity, innovation, and independent thought
  • Strong professional interpersonal and communication skills, both verbal and written to provide clear direction for the business, vendors, internal stakeholders and management
  • Ability to meet deadlines and multi-task efficiently
  • Experience identifying changes, driving improvements and streamlining processes
  • Proficient Microsoft Office Suite; (Word, Excel, PowerPoint, Visio) and Smartsheet


Chinook is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported.  We respect and value different experiences and viewpoints.  We act respectfully toward one another and embrace diversity of people and ideas. Having a diverse workforce made up of team members who bring a wide variety of skills, abilities, experiences, and perspectives is essential to our success. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.

Thank You

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  • Location
    Oakland, California
  • Department
    Quality Assurance (850)
  • Employment Type
    Full-Time
  • Minimum Experience
    Manager/Supervisor