This position oversees business unit -level quality activities and works closely with QRA and department leadership to ensure effective implementation of quality systems. Manages occurrences, leads CAPA investigations and oversees implementation, oversees change control implementation, manages approved variances, participates in internal audits, performs quality data analysis and reporting, contributes to staff training in quality and compliance matters.
Reports occurrences on behalf of designated teams.
Resolves occurrences for business units within vertical.
Collaborates with QRA department to ensure occurrences and quality incidents are being reported appropriately.
Works with appropriate stakeholders to maintain and improve occurrence management system.
CAPA Investigation and Oversight:
Leads assigned CAPA investigations; documents activities and obtains appropriate approvals.
Oversees and tracks CAPA implementation activities and ensures timely closure.
Participates in CAPA Review Board.
Quality Data Analysis and Reporting:
Analyzes and reports on quality data (occurrences, QIs, other metrics) and quality system performance for department management review.
Provides periodic data analysis and quality system performance reports to QRA in support of enterprise quality management systems.
Works with vertical leadership to develop, monitor, and report on Key Performance Indicators.
Variance and Change Control Coordination:
Monitors approved variances to ensure compliance and timely closure.
Oversees implementation of Change Control process as appropriate to processes within the business unit.
Participates in NMDP internal audits.
Identifies process improvement opportunities; coordinates and/or leads process improvement initiatives.
Collaborates with QRA department and contributes to development of training for quality and compliance matters; presents training to new and incumbent staff.
Other duties as assigned.
Quality systems, principles of quality management, risk management, and confidentiality.
FDA regulations applicable to cell therapy and NMDP operations, most particularly 21 CFR 1271 (Good Tissue Practices), 21 CFR 211 (Good Manufacturing Practices – Drugs and Pharmaceuticals), and 21 CFR Part 11 (Electronic Records).
Project management principles.
Demonstrate excellent oral and written communication; advanced interpersonal skills in collaborating with others to gather information; complex problem solving, analysis, and decision making; customer service; proficiency in using relevant NMDP computer software applications; proficiency with Windows, Word, Excel, PowerPoint, internet and databases preferred.
Utilize critical thinking skills and deal with ambiguity; make decisions based on best information available, utilizing appropriate resources and escalating as necessary.
Multi-task and prioritize with attention to detail.
Travel up to 10 times per year, 2-3 days in length.
Must exemplify our Be The Match Standards.
Education and/or Experience:
Bachelor’s degree; Healthcare or Science field strongly preferred. On evaluation, equivalent related experience and/or education may be substituted for the degree requirements.
Two years of experience in a healthcare or science environment. On evaluation, two years in another relevant NMDP position may be substituted for the minimum experience requirement.
At least one year experience with GMP compliance requirements and the application of quality management principles.
Demonstrated data analysis skills; proven high skill level in oral and written communication.
PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
Lean Six Sigma Green Belt or other process improvement/quality management certification.
Advanced Excel proficiency.
Internal Number: 2000002A
About Be The Match
We’re trusted leaders in the field of cellular therapy. We never lose sight of our purpose—delivering cures for blood cancers. From the moment a patient is diagnosed, we are there every step of the way; helping their doctor find a donor, delivering life-saving cells to the patient’s bedside, and supporting patients through recovery and survivorship.
With over 30 years of experience, we are the trusted leaders in advancing the science of transplant, conducting ground-breaking research and providing vital services for patient families when they need them most.
As the world’s largest registry and hub of a global network, our partners count on us to develop innovative solutions to improve transplant and fuel collaborative relationships essential to saving lives.