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 Sr. Manager, Quality Management Systems supports all GxP areas and leads the management and continuous improvement of quality processes within the Chinook Quality Management System. This position includes responsibilities as the process owner for Change Control, Deviations, CAPA, and Quality Risk Management. This position can be based in one of our office locations or remote within the United States and reports to the Director, Quality Management Systems.

Responsibilities include:

• Lead the ongoing training and continuous improvement of Change Control, Deviations, and CAPA as the Process Owner.
• Support the annual assessment of quality culture and develop actions to progress its maturity.
• Lead system implementations including a GXP electronic signature platform.
• Chair/Conduct Change Control, Deviation, CAPA Review Board meetings to maintain oversight of overdue/coming due records and provide support needed to close records.
• Identify trends and ensure appropriate actions are taken.
• Compile and report on quality metrics (e.g., Change Control, Deviations, CAPAs, Quality Agreements, etc.) at Management Review.
• Drive a culture of teamwork, partnership, and continuous improvement with other key departments and stakeholders across the company.
• Facilitate or support the Quality Risk Management program internally.
• Resolve gaps and/or own CAPAs to improve quality processes.
• Train and support staff on the Quality Manual and quality processes as needed.

• Participate in and support regulatory authority inspections and internal audits.

• Provide guidance on best practices and requirements for processes in the Quality Management Systems (e.g., Change Control, Deviations, CAPAs, Management Review, Temperature Excursions, Audits, and Inspections).

Location:

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

Education, Experience, and Skills:

Required:

• BS/BA Degree in related discipline or equivalent experience
• Quality professional with 8+ years of hands-on experience within Quality Management Systems in pharmaceutical or biotech environment
• Experience developing and delivering training
• Familiarity with creating and delivering quality metrics
• Well-organized and detailed oriented professional, with strong verbal and written communication skills
• Excellent computer skills with working knowledge of MS office such as Word and Excel, Visio, and Adobe Acrobat professional. Familiarity with SharePoint.

Preferred:

• Experience with electronic Quality Management Systems as a system or business administrator preferred
• Good knowledge of ICH/FDA/EMA regulatory requirements
• Strong interpersonal skills with ability to effectively participate on multi-disciplinary teams
• Must be self-motivated with the ability to handle, organize and prioritize multiple tasks and able to perform independently to meet deadlines
• Experience with Veeva Vault Quality/QualityDocs/Training applications

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.