Director, Clinical Research Quality Assurance and Regulatory Support
***Please note this is a hybrid role and will require three days a week on-site***
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
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 [click to reveal website link].
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
Our founding promise to the community is as valid today as it was over a century ago: we will care for all children in our region, regardless of the families' ability to pay. Together, we deliver superior patient care, advance new discoveries and treatments through pediatric research, and serve as the pediatric and adolescent, academic medical center for Washington, Alaska, Montana and Idaho - the largest region of any children's hospital in the country.
U.S. News & World Report consistently ranks Seattle Children's among the nation's best children's hospitals. For more than a decade, Seattle Children's has been nationally recognized in key specialty areas. We are honored to be one of the nation's very best places to care for children and the top-ranked pediatric hospital in Washington and the Pacific Northwest.
As a Magnet designated institution, we recognize the importance of hiring and developing great talent to provide best-in-class care to the patients and families we serve. Our organizational DNA takes form in our core values: Compassion, Excellence, Integrity, Collaboration, Equity and Innovation. Whether it's delivering frontline care to our patients in a kind and caring manner, practicing the highest standards of quality and safety, or being relentlessly curious as we work towards eradicating childhood diseases, these values are the fabric of our culture and community. The future starts here.
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.