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This person in this position serves as oversight and management of Seattle Children's Therapeutics (SCTx) regulatory strategy & quality assurance. The Senior Director will be responsible for ensuring that the Therapeutic Cell Production Core (TCPC), and Seattle Children's Therapeutics operate in accordance with regulatory requirements and internal policies. This position reports to the VP and Chief Medical Officer, Seattle Children's Therapeutics (SCTx).

The person in this role will oversee compliance policies and procedures, remains apprised of compliance audits, and foster a culture of ethical business and regulatory practices across SCTx programs and activities. The Senior Director is responsible for working with the SCTx staff to oversee and provide input, as needed, on IND-related issues in support of research products, to partner with TCPC teams as a resource for critical quality management systems including research product release, out of specification (OOS) results, and associated corrective and preventive action (CAPA) procedures. Additionally, the Senior Director will provide quality assurance oversight of GXP (Good Laboratory Practice, Good Manufacturing Practice, and Good Clinical Practice) to ensure compliance with pre-clinical and clinical regulations and standards. This role includes leadership and responsibility over regulatory strategy and compliance, regulatory advice and counseling, product and clinical trial advertising and promotions, and product registrations across the clinical research product portfolio and lifecycle. An integral part of this role is to continue to build strong relationships and advocacy within the institution and external stakeholders such as vendors, collaborators, partners, and regulatory authorities.

An important priority for the Senior Director will be to ensure effective communication, coordination, and collaboration with other leaders and programs across SCTx and SCRI and will provide updates and reports to other Senior Leaders at a frequency and level of detail as is warranted. The Senior Director will oversee development plans, focus on gap analysis to mitigate institutional risk, provide necessary training and education related to regulatory and compliance in collaboration with cross functional areas, as well as ensuring operational excellence and continuous improvement.

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 Children's will terminate automatically upon the termination of the individual's employment at Children's.

Termination of employment does not prohibit the individual from seeking medical or allied health professional staff privileges at Children’s 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

Bachelor’s Degree in life sciences and/or medical background is highly preferred.

Master’s 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

$208,017.00 - $312,025.00 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 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.