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Job Summary

The Quality Assurance (QA) Manager is responsible for ongoing development, implementation and maintenance of quality assurance policies and activities for the University of Michigan Medical School Central Biorepository (UMMS CBR).  The Manager ensures quality and regulatory requirements are met for biospecimens and processes, ensures compliance with applicable quality standards and best practices (e.g. College of American Pathologists Biorepository Accreditation Program, International Society for Biological and Environmental Repositories) and, with Regulatory Affairs, ensures processes are compliant with federal, state and local regulatory requirements for research using human biomaterials (e.g. Department of Health and Human Services, Food and Drug Administration, University of Michigan).
Reporting to the Biorepository Director, the QA Manager leads and maintains the quality management system (QMS), procedures, and controls ensuring conformance with quality standards for human tissue procurement, banking and use. The Manager is responsible for maintaining College of American Pathologists (CAP) accreditation, validating/verifying processes, and maintaining documentation. The Manager ensure compliant on-boarding of new biorepository projects. The Manager handles multiple projects concurrently and communicates with operations and regulatory affairs groups to evaluate and manage human biomaterials quality. 
We seek a strong leader and manager with a demonstrated track record of developing strategy and modifying/implementing policy and procedure to work in a fast-paced and demanding environment. The successful candidate will have a history of driving quality practice while developing a positive and effective relationship with CBR operating units.  The successful candidate will have experience in a production laboratory setting in the biological or clinical sciences.  
  
 

Responsibilities*

  • Lead Quality Assurance and guide operations functions, including biospecimen processing, logistics and banking ensuring biospecimens and services are compliant with QMS specifications
  • Lead ongoing development and execution of CBR’s QMS including strategy and policy
  • Establish ongoing training for colleagues on CBR’s QMS and Document Control System 
  • Lead activities to maintain CBR accreditation by CAP (e.g. continuous improvement projects)
  • Manage the preparation for external inspections by accreditation and certification agencies
  • Review, approve and manage compliant standard operating procedures (SOPs)
  • Perform and manage audits of internal processes and systems
  • Ensure that quality activities and records are in compliance with SOPs and regulatory requirements; ensure proper documentation of quality activities 
  • Report on quality metrics, corrective and preventive action status, internal/external audit results
  • Responsible for assuring that corrective actions and preventive actions are established, tracked trended and proved effective
  • Work with the biorepository IT team and regulatory affairs manager in the development and implementation of compliant biorepository data collection and specimen management systems
  • Responsible for biorepository compliance with regulations regarding equipment, instrumentation, safety, security and monitoring systems
  • Perform as CBR’s internal and external liaison communicating Quality Control (QC) strategies, tactics, and requirements
  • Provide guidance and interpretation of quality standard requirements for CBR functional areas
  • In association with regulatory affairs, ensure policies and procedures are compliant with ethical standards for human tissue use as defined by regulatory agencies
  • Stay abreast of changes in quality standards, regulations, quality metrics, and audit techniques 
  • Perform other QA/QC assignments as required
 

Required Qualifications*

  • Bachelor’s degree in a relevant discipline
  • Five years’ experience in QA functions within the life sciences
  • Familiarity with clinical data and medical terminology 
  • Excellent organizational skills, process and detail oriented and capable of working under minimum supervision with critical time constraints 
  • Strong leadership and management skills; ability to provide direction, facilitation, reinforcement and coaching to individuals and teams
  • Excellent written and oral communication skills and ability to work effectively as a team member 
  • Experience in developing, auditing and managing quality systems 
  • Ability to critically evaluate and troubleshoot complex problems with a customer-oriented approach
  • Proficient in the use of a wide variety of computer applications including the MS Word, Excel, PowerPoint, and project management software.

Desired Qualifications*

  • Master’s degree in an appropriate discipline; preference will be given to candidates with degrees in the biomedical sciences or QA programs
  • Ten plus years’ experience leading a QA Group
  • Proficiency with software for document control and laboratory management
  • Experience with managing CAP compliance 
  • Proficiency in other compliance disciplines, e.g. ISO standards, GLPs, GCPs, CLIA
  • Biorepository experience
  • Clinical or biological production laboratory experience
  • Practical experience with human tissue and/or clinical data
  • Working knowledge of histology, pathology, molecular biology, genomics, translational medicine

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Application Deadline

Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.