Seattle Children's · 4 days ago
Dir, Clinical Research Quality Assurance and Regulatory Support
Seattle, WA
Full-time
Onsite
Lead/Staff, Director/Executive
$181K/yr - $271K/yr
5+ years expSeattle Children's is one of the nation's top five pediatric research centers dedicated to providing hope, care, and cures for children. The Director of Clinical Research Quality Assurance and Regulatory Support will provide strategic direction and leadership in quality analysis and regulatory support for clinical research, ensuring high-quality standards and compliance across the research enterprise.
BiotechnologyHealth CareHospitalHospitality
Responsibilities
Accountable for providing strategic direction and leadership to the Seattle Children's Research Institute in quality analysis and regulatory support for clinical research
Leads overall business planning and direction, contributing current knowledge and future vision of quality management to set QA policies and standards that support the achievement of high-quality clinical research for our patients and families
Responsible for establishing and maintaining a quality assurance and regulatory support program throughout the research enterprise
Responsible for directing, developing, and coordinating staff education that will continue to build and reinforce quality
This position will be the business owner for the electronic regulatory binder system, and its maintenance of part 11 compliance
Qualification
Required
Bachelor's Degree
Minimum of 5-10 years of progressive responsibility for leading the development of total quality/process improvement programs in a research / healthcare environment
At least seven years regulatory experience
Demonstrated successful experience leading growth and development of QA operations, including budgetary accountability
Preferred
Master's Degree in a research or administration field
Demonstrated knowledge of GCP and part 11 validation and compliance
Recognized certification in Quality Assurance or Regulatory Affairs
Proven audit experience in GCP
Benefits
Medical
Dental
Vision plans
403(b)
Life insurance
Paid time off
Tuition reimbursement
Company
Seattle Children's
Hope. Care. Cure. These three simple words capture what we are here to do.
10001+ employees
H1B Sponsorship
Seattle Children's has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (40)
2024 (29)
2023 (34)
2022 (41)
2021 (20)
2020 (13)
Funding
Current Stage
Late StageTotal Funding
$0.72MKey Investors
Fund for Science and TechnologyScaleReadyHyundai Hope On Wheels
2025-08-27Grant
2025-01-08Grant· $0.12M
2024-08-28Grant· $0.4M
Leadership Team
Eric Althoff
Director Of Business Development - Seattle Children's Therapeutics
Howard Jeffries
Senior Medical Director, Strategy & Regional Network
Recent News
2025-10-30
2025-10-18
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