Manager, GxP Business Systems

Information Technology (140) · Seattle, Washington
Department Information Technology (140)
Employment Type Full-Time
Minimum Experience Experienced

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 1/2 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 Manager of GxP Business Systems will be responsible for the management and oversight of GxP IT business systems.  The role will be responsible for system implementations and ongoing release management and support of GxP systems, adhering to regulatory requirements   The Manager will be the IT Subject Matter Expert (SME) and own the IT Computer System Validation policies and procedures. This position will report to the Executive Director of IT.

 

Responsibilities include:

 

  • This role is responsible for the definition of functional strategy of GxP Quality Systems in relation to computer systems and validation and provides oversight of computerized system validation activities and related vendors from an IT perspective
  • Work collaboratively with counterparts in Quality and GXP functions to ensure GXP computer systems are selected, implemented, and maintained in a compliant fashion
  • Provide guidance and IT oversight for validation activities of computer systems hosted and maintained by service providers
  • Partner with Quality on the development and ongoing maintenance of GXP computer system validation protocols, URS, test scripts, reports, and associated deviations, IT SOPs and other SOPs related to GXP computer systems
  • Monitor and ensure conformance to 21 CFR Part 11 regulations and guidance that impact computer systems compliance
  • Provide support for changes to GXP computer systems
  • Support the maintenance of computer systems compliance documentation
  • Implement IT Computer System Validation (CSV) and Computer System Assurance (CSA) standards and adhere to ongoing compliance requirements
  • Lead and/or support teams developing new or improving existing Quality, Clinical, Manufacturing, Pharmacovigilance and Information Technology GXP computer system
  • Represent IT on cross-functional projects related to data integrity/protection, and other computer systems efforts
  • Establish, monitor and drive improvements to GXP computer systems
  • Represent IT on risk assessment activities for GXP systems


Education, Experience, and Skills:


  • Minimum of 5 years experience in a GxP IT systems management role within a pharmaceutical development setting
  • Bachelor's Degree in Computer Science, Engineering, Pharmaceutical Sciences, or a related scientific discipline required
  • A strong understanding of computer systems validation, data integrity in accordance with the 21 CFR Part 11, and GAMP principles applied across clinical, manufacturing and Quality Management Systems.
  • Demonstrated ability to define, create and implement procedures and processes which ensure compliance to GXP and regulatory standards
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company
  • Strong technical, analytical, and writing skills to identify and solve problems and document them appropriately
  • Working knowledge of GxP processes such as GMPs (Good Manufacturing Procedures), GCPs (Good Clinical Practices), and Drug Development processes
  • Demonstrated project management experience and skills, with the ability to coordinate multiple projects in a demanding fast-paced environment
  • Experience implementing GxP systems such as Quality Management Systems, Learning Management Systems, eTMF and CTMS
  • Experienced in release management of computerize systems in adherence to regulatory requirements
  • Experience with the Veeva GxP suite of applications preferred.



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.

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  • Location
    Seattle, Washington
  • Department
    Information Technology (140)
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced