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Coordinates and supervises defined Quality Management functions in support of the organizations strategic objectives to assure continuing compliance with FDA cellular therapy regulations, and promote highest standards of safety for donors, patients and products. Provides expertise and consultation to operations departments regarding quality management systems. Performs advanced and/or specialized quality management tasks. Supervises Quality Management staff. Minimum Education: Bachelors degree in medical technology or other health science-related field. On evaluation, five years in a quality management role, in addition to the minimum experience required, may be substituted for the degree requirement. Certification with the American Society of Quality (ASQ) or certification in a continuous process improvement methodology (e.g., Lean, Six Sigma) desired. Minimum Experience: Five years of experience in a position which required theapplication of quality management principles within an FDA-regulated industry such as biologics, blood, tissues, pharmaceutical, or medical device. Three years working with Good Manufacturing Practice (GMP) and/or Good Tissue Practice (GTP) regulations. Two years supervisory or progressively responsible project or team leadership experience which achieved measurable results or outcomes that were obtained through the work of others. Key Knowledge: Demonstrated applied knowledge of quality management systems, and US Food and Drug Administration (FDA) regulations regarding Good Manufacturing Practice (GMP), Good Tissue Practice (GTP), and Good Documentation Practice (GDP). Key Skills: Ability to meet deadlines and manage multiple projects and tasks simultaneously; strong oral and written communication skills; supervisory and leadership skills; highly proficient in Microsoft Word and Excel; excellent strong interpersonal, customer service and collaborative skills; able to work both independently and as part of a team.
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Be The Match