Manager, Quality Assurance (H)

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The Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami Miller School of Medicine is actively seeking a dedicated Quality Assurance Manager to oversee the quality control and assurance of all clinical trials within the Clinical Trials Division and cGMP operations. Reporting to the Executive Director of the Clinical Research Cellular Therapy Manufacturing Program (CRCMP), this full-time position is critical in supporting the Medical School's vision, mission, goals, and objectives by ensuring that clinical trials are conducted in compliance with relevant regulatory standards and that the quality management system of the CRCMP complies with all cGMP requirements for cell manufacturing for clinical applications.

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.

Education:

Bachelor's degree; Master's degree is preferred

Certification and Licensing:

Clinical Research, Research Compliance, or Auditing GCP related fields is preferred

Experience:

5 years of relevant experience; preparing submissions and dealing with the FDA and other regulatory agencies, is preferred

Knowledge, Skills, and Abilities:

• 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

Department Specific Functions

• Responsible for establishing and implementing robust quality control systems, managing the efficient review of submitted research and ensuring consistency with regulatory requirements

• Includes accurate and timely processing, tracking, and filing of submissions to regulatory agencies such as FDA, FACT, and AABB.

• Maintaining meticulous records of IRB actions, documenting communications with investigators, regulatory entities, and other stakeholders involved in the conduct of research.

• Responsible for maintaining facility accreditations and managing the renewal process

• Responsible for working on the CMC sections of the IND, ensuring comprehensive documentation and compliance with all regulatory guidelines

• Oversees quality assurance, assessment, and compliance of clinical trials, ensuring all activities adhere to GCP, ICH, and FDA regulations

• Determines that Standard Operation Procedures (SOPs), are accurately defined and followed; which should be reviewed annually to ensure accuracy and appropriateness to actual practices

• Responsible for ensuring compliance with all applicable federal, state, local regulations that dictate Good Documentation Practices

• Conducts comprehensive internal audits of the entire quality system and provides proper corrective/preventative recommendations

• Responsible for CAPA review and implementation

• Manages Adverse Event reporting and documents corrective action as appropriate

• Prepares for and supports external monitoring and audits of clinical trials, ensuring trial consistency with IRB approved proposals and adherence to relevant laws and regulations

• Summarizes and reports any findings or deviations to senior management

• Leads the development and implementation of regulatory compliance strategies within the ISCI's cGMP operations, including the monitoring and auditing of clinical manufacturing processes

• Generates, submits, and manages Investigational New Drug (IND) submissions and Serious Adverse Effects (SAE) reports, responding to regulatory agency inquiries and maintaining correspondence files

• Interfaces with regulatory agencies, serving as a liaison to ensure that all manufacturing activities are compliant with current regulations

• Organizes and directs training programs for ISCI employees on regulatory requirements governing clinical and manufacturing practices, including HIPAA compliance

• Designs and oversees monitoring programs that ensure the safety of human and animal subjects involved in clinical trials and manufacturing processes

• Regularly review and adapt processes to incorporate new quality and regulatory changes in industry trends

• Develops and manages systems to support auditing activities, including organizing panels of experts for reviews and risk analysis

• Performs other related duties as required, ensuring all responsibilities are executed in accordance with the institution's standards and objectives

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 physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

Job Status:

Full time

Employee Type:

Staff

Pay Grade:

H13