Quality Liaison - Hybrid/Remote

REQUIRED QUALIFICATIONS: 

Knowledge of:

• Quality systems, principles of quality management, risk management, and confidentiality.
• FDA regulations applicable to cell therapy (preferably 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.

Ability to:

• 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.

Education and/or Experience:

• Bachelors degree; Healthcare or Science field strongly preferred. Associates degree with additional applicable experience may be considered.
• Five years of professional experience in a Quality position in an FDA-regulated industry such as biologics, blood, tissue, pharmaceutical or medical device. healthcare or science environment. Advanced education in quality management or regulatory compliance may substitute for up to 2 years of experience.

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)

• Direct experience with 21 CFR 1271 and/or 21 CFR 211 regulations.
• Experience hosting or participating in supplier quality audits and/or regulatory inspections.

Proof of being up to date on COVID-19 vaccination, including a booster, when eligible, with acceptable documentation is required for employment. NMDP will consider all requests for medical or religious accommodation.