Manager, Quality Assurance

Manager, Quality Assurance

The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full-Time Manager, Quality Assurance - Remote to work at the UHealth campus in Miami, Fl.

The Manager, Quality Assurance conducts routine, focused, and directed audits of human subject research protocols to ensure compliance with federal and local regulations and guidelines, and research site specific standard operating procedures. The incumbent on this position advises appropriate institutional officials of deficiencies, and recommends necessary corrective actions, with follow up to ensure that needed actions have been implemented. The Manager, Quality Assurance also trains and mentors quality assurance auditors.

Core Job Functions

• Remains in compliance with federal, state, and local regulations, and extramural agencies' requirements, and conducts inquiries of laboratories and research protocols.
• Prepares reports of investigations and inquiries for internal or external use. Assists in the preparation and presentation of educational programs.
• Conducts the preparation of research teams for FDA or other regulatory agency audits.
• Assists research teams with required written responses to observations resulting from audits conducted by regulatory agencies.
• Reviews audit reports and plans of quality assurance auditors.
• Monitors new legislation or changes in regulations that might affect the University's compliance in conducting research and recommends changes to administrative policies and procedures.
• Creates, revises, and maintains internal policies and standard operating procedures, as well as University-wide policies intended to assist University researchers in maintaining compliance with research standards and guidelines.
• Assists with the preparation of annual reports, summarizing efforts taken and changes to be implemented at both University and department levels.
• Maintains quality assurance related databases and electronic and paper audit files.
• Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures.
• Ensures employees are trained on controls within the function and on University policy and procedures.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

Core Qualifications

• Education: Bachelor's Degree in relevant field
• Experience: Minimum 5 years relevant experience
• Knowledge, Skills and Attitudes:
• Ability to maintain effective interpersonal relationships
• Ability to communicate effectively in both oral and written form
• Skill in collecting, organizing, and analyzing data
• Ability to recognize, analyze, and solve a variety of problems
• Ability to exercise sound judgment in making critical decisions

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

Job Status: Full time

Employee Type: Staff