Head of Quality Assurance

Quality · Seattle, Washington
Department Quality
Employment Type Full-Time
Minimum Experience Experienced

Chinook Therapeutics is a biotechnology company developing precision medicines for patients with kidney diseases.  We apply our proprietary research platform to discover and develop therapeutics with novel mechanisms of action against key kidney disease pathways. The development focus is on rare, serious disorders with clear unmet medical needs and defined and rapid clinical development opportunities.  Chinook recently in-licensed a late-stage product, atrasentan, and plans to initiate a phase 3 trial for chronic kidney disease during 2020.  Our pipeline has several other internal programs at the validation and lead optimization stages, the first of which is rapidly progressing to enter clinical trials by 2021.  We are also evaluating business development opportunities for early and late-stage clinical assets to enhance the pipeline.

Chinook has raised a $65 million Series A financing from top tier venture capital firms Versant Ventures, Apple Tree Partners, and Samsara BioCapital.  We are a growing team of approximately 30 employees and are based in Vancouver, British Columbia and Seattle, Washington.

 

Position:

The Head of Quality Assurance will be responsible for establishing the Quality Framework for Chinook Therapeutics and providing QA oversight of all GXP functions. Reporting to the VP, Regulatory Affairs, this individual will be responsible for setting up, maintaining, and continuously improving the Quality Management System, in compliance with FDA and other applicable regulations.  This position may be located in either Chinook's Seattle or Vancouver location.


Responsibilities include:

  • Plan, create and develop GXP Quality Systems to ensure compliance with relevant regulations, in a development phase-appropriate manner.
  • Establish governance structure and metrics for quality oversight.
  • Maintain and optimize Quality Assurance programs including (but not limited to) document control, change control, lot disposition, incident management and SOPs.
  • Authors SOPs, Batch Records, Forms/Templates, Process Support Documentation & Training Materials.
  • Edits documentation for clarity, consistency, organization, and effectiveness.
  • Performs Executed Logbook and Executed Batch Record reviews.
  • Providing consultation and direction on quality assurance and GCP/GMP/GLP compliance to supported functions.
  • Assures the planning and conduct of periodic compliance training on GLP, GMP and GCP regulations.
  • Ensuring a robust and risk-based audit program is successfully realized throughout our vendor network.
  • Managing and coordinating all associated GxP regulatory inspections.
  • Development and management of value added quality agreements with CMOs, CROs, partners and suppliers.
  • Participate in cross-functional teams, providing feedback and support.
  • Identify, partner with, and oversee external vendors and consultants in support of the company’s Quality Management needs.

 Education, Experience, and Skills:

  • Minimum Bachelor’s degree required. Advanced degree preferred.
  • Minimum of 15 years' quality assurance experience in pharmaceutical/biotechnology industries.
  • Highly experienced and motivated individual that is happy to roll his/her sleeves up in a highly visible role within the organization.
  • Excellent interpersonal and communication skills, including the ability to influence behaviors and negotiate and resolve challenges with diplomacy.
  • Expert knowledge and practical experience of GCP, GLP, and GMP.
  • Expertise in supporting FDA pre-approval inspections.
  • Experience in representing QA on cross functional development teams.
  • Experience in supporting global clinical studies.
  • Excellent working knowledge with the practical implementation of FDA and EMA regulations and guidelines in GxP environments.
  • Continuous development into current regulations, guidelines and industry standards.
  • Experience in working in a company transitioning from an R&D to Commercial organization.

 

 

Chinook is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.

 

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  • Location
    Seattle, Washington
  • Department
    Quality
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced