U

University of Rochester

Private research university in Rochester, NY

Cellular Therapy Program Quality Manager

Regulatory Compliance & EthicsConfirmed live in the last 24 hours
Full-timeRochester, NY, USA$70.6k - $105.8kIn-person

About the Job

Requirements

  • A bachelor's degree and five years of relevant experience are required, or an equivalent combination of education and experience.
  • Ability to advise and guide multiple clinical departments on federal and state regulatory requirements and accreditation standards.
  • Ability to coordinate and facilitate systematic analysis of quality and patient safety events and support timely risk-reduction strategies.
  • Ability to support departmental QAPI plans and align them with hospital quality and safety goals and policies.

Responsibilities

  • Develop and implement programs, policies, and practices to ensure compliance with organizational and governmental standards, and recommend updates.
  • Maintain compliance with country-mandated regulatory requirements and document legal regulations that may affect organizational policies and procedures.
  • Develop and deliver training programs to improve employee awareness of and adherence to safety and quality standards.
  • Maintain communications with leadership regarding quality and safety activities.
  • Coordinate and conduct assessments of internal controls to ensure compliance with regulatory commissions and authorities.
  • Develop programs and processes to manage complaint cases brought to regulatory authorities and develop process improvements to prevent future complaints.
  • Manage a domain of quality and/or patient safety.
  • Coordinate and facilitate credible, comprehensive, systematic analyses and, when applicable, assist in developing associated risk-reduction strategies in a timely manner, with reporting to state regulatory agencies as required.
  • Facilitate interdepartmental team effectiveness.
  • Provide support and serve as a liaison between hospital Quality Improvement leadership and department quality physician leadership and quality administrative support to ensure departmental QAPI plans are effective and aligned with hospital management plan quality and safety goals and hospital policy.
  • Address organizational quality and safety needs.
  • Monitor and investigate patient safety events reported in the safety event reporting system.
  • Coordinate with clinical departments to identify safety events for review and evaluation by Risk Management and Quality Improvement leadership for possible comprehensive analysis or department-level review.
  • Provide support for regulatory survey activity, including announced, unannounced, desk, or written activities.
  • Perform other duties as assigned.

About the Company

University of Rochester

Private research university in Rochester, NY

The University of Rochester is a research university with programs spanning the humanities, health care, business, education, music, engineering, and the sciences.

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