- 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
- 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
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.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.