Sr Quality & Compliance Spec

Responsibilities

• Identifies the need for and conducts audits of internal processes to ensure compliance with policy and regulations.
• Develops and maintains relationships with regulatory commissions/authorities.
• Captures and manages internal controls to ensure compliance as required by regulatory commissions/authorities.
• Develops programs and processes to manage complaint cases brought to regulatory authorities and recommends process improvements to avoid future complaints.
• Prepares reports for leadership on compliance and quality metrics, evaluates and provides insight to support continuous improvement.
• Mentors more junior team members.

Requirements

• Identifies the need for and conducts audits of internal processes to ensure compliance with policy and regulations.
• Develops and maintains relationships with regulatory commissions/authorities.
• Captures and manages internal controls to ensure compliance as required by regulatory commissions/authorities.
• Develops programs and processes to manage complaint cases brought to regulatory authorities and recommends process improvements to avoid future complaints.
• Prepares reports for leadership on compliance and quality metrics, evaluates and provides insight to support continuous improvement.
• Mentors more junior team members.

Qualifications

• Bachelor's degree and 5 years relevant experience required
• Or equivalent combination of education and experience

Skills

• Collaborates and guides development of work processes to meet departmental needs and industry standards.
• Develops QA response and prepares exhibits as needed.
• Conducts internal quality audits, prepares reports, tracks responses and monitors/documents corrective action taken.
• Evaluates and makes recommendations regarding audit outcomes, data analysis and departmental key indicators.
• Interacts with Medical Center QA and Process Improvement teams regarding quality initiatives and root cause analysis, as assigned.
• Reviews documents for compliance.
• Develops and monitors protocol specific quality assurance plans, if required, based on position/department.
• May develop, manage and monitor external vendor assessment program.
• Reviews and/or approves procedures, validation plans and other quality related documents, as applicable.
• Manages external audit schedules and facilitates quality audits by external parties.
• Communicates with auditors to establish audit objectives/time frames.
• Coordinates interviews/provides documentation.
• Prepares QA responses to audit findings and coordinates responses.
• Oversees occurrence management initiatives and assists staff in developing quality improvement plans.
• Directs development and tracks progress of Corrective Action and Preventative Action (CAPA) plans.
• Provides department management with regular updates on quality systems initiatives.
• Analyzes data within the occurrence management system for trends.
• Researches and maintains current knowledge of developing trends in quality systems methods and state and federal regulations and incorporates best practices into department programs.
• Conducts risk assessments against regulatory/industry standards.
• Develops and monitors document management process, ensuring related documents and records are in accordance with departmental and UR policy, state and federal guidelines.
• Maintains QA documents and records according to standards.

Benefits

The University of Rochester offers a comprehensive benefits package including health insurance, retirement plans, and paid time off. For more details, please refer to the Employee Handbook.

Pay

$70,600.00 - $105,800.00

Schedule

Full time, 40 hours per week