Departmental Quality Specialist-Regulatory

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A Brief Overview
The Departmental Quality Specialist-Regulatory is responsible for assisting the Sr. Quality Manager ensure accreditation readiness by all governing bodies including and not limited to CAP, CLIA, FDA, CMS, JCOH, state specific DOH. Provides guidance to facilitate knowledge of regulatory clinical standards and systems implemented to sustain adherence. Assist departmental leadership with assuring that event reporting, analysis, and mitigation are compliant with regulatory bodies. data collection, entry, manipulation, and analysis to produce valid integrated and actionable information for use by improvement groups. The Departmental Quality Specialist-Regulatory will also to improve quality assurance, workflows, and processes within the Department of Pathology and Laboratory Medicine and utilizes Six Sigma design and the CHOP improvement framework to facilitate improvement projects. Coordinates with interdisciplinary teams to improve processes that ultimately improve the patient experience. Learns quickly, works independently, and is relentless in the quest for continual quality improvement and assurance that Pathology and Laboratory Medicine meets rigorous regulatory standards.

What you will do

• Knowledgeable of regulatory processes and the works to ensure regulatory compliance within our department.
• In consultation with the Sr. Quality Manager, acts as the subject matter expert to identify and develop solutions for regulatory requirements in pathology and lab medicine field in support of major regulatory submission programs as needed.
• Must be knowledgeable of all regulatory pathways and designations.
• Communicate directly with regulatory agencies to ensure full compliance, as needed.
• In consultation with the Sr. Quality Manager, serves as a resource by providing regulatory consultation services, e.g., assisting with exemption determinations, communicating with regulatory agencies such as responses to new regulations, remediation of non-conformance etc.
• Assist department with accreditation readiness across the system: works to achieve continual readiness for regulatory visits through standards education to help facilitate compliance across laboratory department, clinical teams, and ambulatory care.
• In conjunction with Sr. Quality Manager, collaborates with leaders within and out of the department to eliminate barriers in the regulatory preparedness journey.
• Consultant to inter-professional teams to validate regulatory compliance with clinical practice
• Monitor compliance with event reporting requirements and provides direction for regulatory and accreditation activities related to nonconforming event management.
• Takes initiative in problem solving and communicates unresolved issues to leadership.
• In consultation with the Sr. Quality Manager, initiates intradepartmental apparent cause analyses when appropriate and leads associated investigative and improvement work.
• Leads and/or participates in quality improvement projects and activities internal to the department of Pathology and Laboratory Medicine.
• Performs scheduled and focused audits as required. Generates reports detailing findings for submission to management, particularly related to laboratory regulatory requirements.

Education Qualifications

• Bachelor's Degree in biological science, medical technology, or other health related field. Required

Experience Qualifications

• At least three (3) years in quality improvement, and quality management education Required
• Formal training in lean six sigma, with experience in lean six sigma methodologies, knowledge of and/or experience in data tracking, trending and statistical process control analysis Preferred

Skills and Abilities

• Experience applying data analysis to drive fact-based decisions.
• Ability to work independently, take initiative when necessary and maintain confidentiality.
• Ability to develop and maintain effective relationships and work collaboratively
• Teaching/coaching skills are required
• Ability to manage multiple projects, work independently, and implement problem-solving capabilities

Licenses and Certifications

• Six Sigma Green Belt (CSSGB) - American Society for Quality (ASQ) - upon hire - Preferred

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.

Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.

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