Sr. Director, Quality Management Systems (QMS)

Company: NewYorkLifeScience.com
Location: San Francisco
Posted on: March 20, 2023

Job Description:

Sr. Director, Quality Management Systems (QMS)Quality Assurance (850) - Seattle, WashingtonCompany: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. Director, Quality Management Systems (QMS), is a vital member of the Chinook Quality leadership team, responsible for driving and delivering the activities necessary to develop, implement, and continuously improve Chinook's GxP QMS. The Sr. Director will be responsible for the implementation of electronic systems in support of QMS processes, plan for and support future clinical and commercial manufacturing and supply chain needs, and support or lead quality initiatives to support the growth of the organization. The Sr. Director of Quality Management Systems will report to the Vice President of Quality.Responsibilities include:

• Select, implement, manage, and oversee GxP electronic systems.
• Manage a portfolio of interrelated continuous improvement projects and initiatives.
• Develop, implement, manage, continuously improve, and oversee: Document Management, Training Management, Change Control, Management Review (MR), Annual Product Quality Review (APQR), Deviation/CAPA/ Risk Management, and GxP Computer System Assurance.
• Guide and support GxP process owners with implementation and improvement /optimization of key functional area processes.
• Establish and improve policies and standard operating procedures for efficient and compliant management of GxP QMS processes.
• Establish, track and report quality metrics for QMS processes and present improvement opportunities at Management Review meetings.
• Implement phase appropriate, risk-based, fit-for-purpose approaches to QMS processes.
• Support the Chinook Quality management team in ensuring that QMS processes comply with applicable regulatory standards, regulations and guidelines.
• Maintain awareness of new regulations, technologies, trends and apply as relevant.
• Manage resources to achieve company, department and functional area goals and objectives.
• Contribute to the development and maintenance of a positive team-focused company culture.Location: Chinook has offices located in Seattle WA, Oakland CA, and Vancouver BC
  • This position may be on-site at any Chinook office or remote (within US or Canada). Preference given to candidates located in the greater Seattle, Vancouver, or San Francisco Bay areas.Education, Experience, and Skills:Required
    • BA or BS degree in a scientific discipline or comparable experience.
    • 15+ years of experience in a pharmaceutical or biotech environment in Quality Assurance, Quality Control, QMS or a GxP operational role.
    • Minimum of 5 years of managing Quality Management Systems.
    • Minimum of 5 years of experience with Phase 3 and/or commercial bio-pharm manufacturing.
    • 3+ years of experience in an outsourced manufacturing environment.
    • Strong technical skillset and experience in implementing and validating cloud-based (hosted) computer systems.
    • Position requires 10-20% travel.Preferred:
      • Must have excellent verbal, written, interpersonal, and organizational and communication skills.
      • Demonstrate ability to work independently and manage staff and projects (direct and indirectly) and variable workloads with demanding timelines.
      • Ability to manage tasks with competing priorities or deadlines.
      • Ability to perform at high levels while collaborating with key stakeholders in an exciting, dynamic environment with a high degree of engagement and enthusiasm.Salary Range: $242,000 - $283,000
        • Paid parental leave
        • Vacation and Sick time
        • Volunteer time off
        • 15 Paid Holidays
        • Hybrid Work
        • Retirement Matching
        • Financial wellness programs
        • Employee assistance programs (EAPs)
        • Internal learning & development coursesChinook 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.Chinook Therapeutics is an Equal Opportunity EmployerNewYorkLifeScience.com, owned and published by Info.Resource, Inc. ,is a resource
          for the life science industry in the state of New York.

Keywords: NewYorkLifeScience.com, San Francisco , Sr. Director, Quality Management Systems (QMS), Executive , San Francisco, California