Dir, Clinical Research Quality Assurance and Regulatory Support

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.

• Required Education and Experience
• 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.

• Required Credentials
• N/A.
• 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.

• Compensation Range
• $180,884.00 - $271,326.00 per year
• Salary Information
• This compensation range was calculated based on full-time employment (2080 hours worked per calendar year). Offers are determined by multiple factors including equity, skills, experience, and expertise, and may vary within the range provided.
• Disclaimer for Out of State Applicants
• This compensation range is specific to Seattle, positions located outside of Seattle may be compensated differently depending on various factors

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• Benefits Information
• 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 .
• About Us
• Hope.

Care. Cure. These three simple words capture what we do at Seattle Children's - to help every child live the healthiest and most fulfilling life possible. Are you ready to engage with a mission-driven organization that is life-changing to many, and touches the hearts of all? #

HOPECARECURE

• As one of the nation's top five pediatric research centers, Seattle Children's Research Institute is dedicated to providing hope, care, and cures to help every child live the healthiest and most fulfilling life possible.

Our investigators are involved in hundreds of projects that cover every phase of research, from studying how diseases work to improving investigational therapies. They have pioneered groundbreaking cystic fibrosis treatments and cutting-edge cancer therapies that help a child's immune system defeat cancer, and made other major contributions to pediatric medicine. Researchers work in close collaboration with one another, their colleagues at partner institutions including the University of Washington and Fred Hutch and our healthcare providers at Seattle Children's Hospital, one of U.S. News & World Report's top children's hospitals. This collaboration is one of our key strengths, allowing our faculty to draw on a variety of disciplines and techniques as they pursue solutions to some of medicine's most complex problems. We are committed to not only treating disease but to eliminating it. Help us achieve our vision of being a worldwide leader in pediatric research aimed to improve the health and well-being of children. If you are interested in a challenging career aimed at groundbreaking research, Seattle Children's Research Institute is the place for you.

• Our Commitment
• Seattle Children's welcomes people of all experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our patients and families.

Our organization recruits, employs, trains, compensates, and promotes based on merit without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. The people who work at Seattle Children's are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves. Seattle Children's is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.