Dir, Clinical Research Quality Assurance and Regulatory Support

Seattle Children's • Seattle, WA

36d

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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.

Benefits

• Seattle Children’s offers a generous benefit package, including medical, dental, and vision plans, 403(b), life insurance, paid time off, tuition reimbursement, and more.
• Additional details on our benefits can be found on our website www.seattlechildrens.org/careers/benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director