Associate Director/Director, Quality Assurance (Biologics/Device)

Quality Assurance (850) · Seattle, Washington
Department Quality Assurance (850)
Employment Type Full-Time
Minimum Experience Senior 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 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 Associate Director/Director of Quality Assurance will serve as a quality professional responsible for QA oversight and approvals as it relates to execution of the QMS throughout the product lifecycle from early phase through commercial. This critical role will also be responsible for the quality management of third-party suppliers/contract manufacturers for assigned biologic and combination products. This role supports Chinook’s quality culture through collaborating externally and with Analytical Development, Quality Control, Quality Compliance, Clinical Quality, Supply Chain, CMC & Technical Operations, and other internal stakeholders to ensure product quality, data integrity and regulatory compliance of biologic and device programs. In addition, this individual will be the product quality lead for the assigned products. The Associate Director/Director of Quality Assurance will preferably be based in one of the Chinook West coast offices (Vancouver, BC; Seattle, Washington; Oakland, CA; San Diego, CA) but can be remote and will report to the Head of Quality Assurance.

 

Responsibilities include:

 

  • Quality representative on multiple product cross-functional teams.
  • Review and approve records/documents including but not limited to validation protocols and reports, transfer documents, change controls, deviations, product specifications, stability protocols and temperature excursion memos
  • Oversee quality of third-party supplier’s services (manufacturing, filling, packaging, shipping as appropriate) and maintain regular oversight via periodic monitoring, auditing and quality agreement reviews
  • Contribute to or make product quality decisions
  • Responsible for product disposition
  • Works with CMC Technical Operations and Regulatory Affairs to author and review applicable sections of IND/IMPD and NDA/MAA submissions and contributes to regulatory agency information requests.
  • Represents product quality during inspections
  • Serves as the quality expert for assigned products
  • Contributes to the development and maintenance of a positive team-focused company culture and a culture of quality by collaborating across all departments to accomplish company objectives.
  • Supports regulatory inspections and internal audits, including gap identification and closure for inspection readiness.
  • Supports the continuous improvement of processes and systems to assure the quality of Chinook products. Provide input and change management for quality improvements affecting QA.
  • Supports implementation of Quality Management System processes.
  • Participates in the selection and auditing of contract organizations as needed.
  • This position requires domestic and international travel up to 20%.
  • Other duties as assigned.


Education, Experience, and Skills:

 

  • The position requires a BS or BA degree or equivalent preferably with a science focus of chemistry, biochemistry, microbiology or equivalent program.
  • Minimum of 10 years of experience in the pharmaceutical industry within the Quality Assurance function supporting biologics and device.
  • Minimum of 5 years of “QA on the floor” responsibilities for biologics manufacturing
  • Demonstrated track record of third-party supplier management
  • Expert in applicable biologic and device regulations
  • Working knowledge and ability to interpret cGMP regulations (e.g. FDA, EMA, NMPA) and guidances (e.g. ICH, ISO).
  • Experience managing quality oversight for both development and commercial products
  • Demonstrates initiative and proactively provides collaborative support to the internal and external stakeholders as a credible communicator.
  • Must have high degree of professionalism, and ability to work with limited direction to follow through with specific tasks. Continuously demonstrates a positive, ‘can do’ and service-oriented attitude.
  • Strong oral and written communicator; detail-oriented with a commitment to accuracy. Ability to plan and organize work in an efficient manner, multi-task and shift priorities quickly while working under time constraints. Skilled in developing collaborative internal and external relationships.
  • Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).



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
    Quality Assurance (850)
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor