Job Information
University of Miami Manager, Quality Assurance (H) in Miami, Florida
Current Employees:
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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 (https://www.hr.miami.edu/careers/eo-ada/index.html) for additional information.
Job Status:
Full time
Employee Type:
Staff
Pay Grade:
H13
The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation.
The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit welcome.miami.edu/about-um to learn more about our points of pride.
The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings.
Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019.
The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022.
Transforming lives
With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.
The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value. Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service.