Company:

Chronic kidney diseases are a severe and growing worldwide problem with a lack of effective treatments often leading to dialysis, transplantation, and high costs to health care systems. Up to 10% of the global population suffers from kidney disease and in the U.S. alone, kidney diseases account for over $130 billion in annual costs.

At Chinook Therapeutics our purpose is to discover and develop precision therapies to preserve kidney function and make dialysis and transplant unnecessary for people living with kidney disease. We strive for excellence in all we do and think big in our innovation; our highest priority is to do the right thing for patients while working together and having a whole lot of fun!

Our pipeline of precision medicines targets rare, severe kidney disorders with few currently approved therapies. For more information on Chinook and our pipeline, check out our site www.chinooktx.com/about & www.chinooktx.com/pipeline. We trade on Nasdaq under the ticker symbol KDNY and are headquartered in Seattle, WA with offices in Vancouver, BC, and Oakland, CA.

We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team. We are building a diverse and inclusive workforce –come and be a part of our growth.

At Chinook, we are building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate is not exactly as we describe it here.

Position:

The Director of Quality Assurance (QA) will be responsible for QA oversight and approvals as it relates to execution of the Quality Management Systems (QMS) for early phase small molecule programs from raw material to final distribution. This critical role will also be responsible for the quality management of third-party suppliers/contract manufacturers for assigned products. This role supports Chinook’s quality culture through collaborating externally and internal stakeholders to ensure product quality, data integrity and regulatory compliance of small molecule programs. This individual will also be the product quality lead for assigned products. In addition, this individual will help identify and implement QMS process improvements. This position will report to the Head of Quality Assurance and Product Quality and can be based in one of our office locations or can be remote within the United States.

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, CAPAs, product specifications, technical reports, stability protocols, product complaints and temperature excursion related documentation
• Onboard suppliers associated with program
• Oversee quality performance of third-party supplier’s services (manufacturing, filling, packaging, and storage/shipping) 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. Lead, provide input and change management for quality improvements
• 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

Location:

This position may be located at any Chinook office location or remote (within US)

Education, Experience, and Skills:

Required:

• The position requires a BS or BA degree or equivalent preferably with a science focus of chemistry, biochemistry, microbiology, or equivalent program
• Minimum of 12 years of experience in the pharmaceutical industry within the Quality Assurance function supporting small molecule
• Minimum of 5 years of “QA on the floor” responsibilities for small molecule manufacturing
• Demonstrated track record of third-party supplier management
• Experience managing quality oversight for development 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

Preferred:

• Expert in applicable small molecule regulations
• Working knowledge and ability to interpret cGMP regulations (e.g. FDA, EMA, NMPA) and guidance (e.g. ICH, ISO)
• Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)

Benefits:

• Paid parental leave
• Vacation and Sick time
• Living organ donor leave
• Volunteer time off
• 15 Paid Holidays
• Hybrid Work
• Flexible scheduling
• Healthcare plans
• Retirement Matching
• Financial wellness programs
• Employee assistance programs (EAPs)
• Internal learning & development courses

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 cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.