Sr. Director of Regulatory Strategy and Quality Assurance
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Job Location:
Yearly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Required Education and Experience
MS Degree.
Formal Training in regulatory and quality assurance as it relates to phase appropriate clinical research product compliance with cGXPs (Current Good Laboratory Practice Current Good Manufacturing Practice and Current Good Clinical Practice).
Formal Training in Regulatory Sciences.
Experience in Basic Research Laboratory Operations.
Required Credentials
Prior to start of employment must obtain and maintain in good standing medical or allied health professional staff privileges that are not limited revoked suspended conditioned or probationary except for normal probationary periods due to initial appointment.
All medical and allied health professional staff members are provisional for the first year.
Any and all medical or allied health professional staff privileges at Childrens will terminate automatically upon the termination of the individuals employment at Childrens.
Termination of employment does not prohibit the individual from seeking medical or allied health professional staff privileges at Childrens as a non-employee in any category for which the individual qualifies.
Questions regarding medical or allied health professional staff privileges may be directed to Medical Staff Services.
Preferred
Bachelors Degree in life sciences and/or medical background is highly preferred.
Masters Degree in a relevant scientific field is highly preferred.
Prior experience leading cross functional teams.
Substantial experience in Regulatory GXP (GLP GMP and GCP) Quality Assurance a minimum of 15 years in total (with 10 years in progressive management or leadership roles) is required though at least 20 years is strongly preferred.
Compensation Range
$208017.00 - $312025.00 per yearSalary 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 Childrens 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 Us
Hope. Care. Cure. These three simple words capture what we do at Seattle Childrens 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 nations top five pediatric research centers Seattle Childrens 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 childs 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 Childrens Hospital one of U.S. News & World Reports top childrens 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 medicines 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 Childrens Research Institute is the place for you.
Our Commitment
Seattle Childrens 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 Childrens 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 Childrens is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
About Company
One of the best children's hospitals in the country, as ranked by U.S. News & World Report, Seattle Children's Hospital, Foundation and Research Institute advance pediatric care.
