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.
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
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.
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
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
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.
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.
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.
The University of Michigan is an equal opportunity/affirmative action employer.
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For..." survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.