The Manager of Regulatory Affairs and Quality Assurance Department is responsible for providing regulatory and quality assurance leadership and guidance throughout Eurofins CellTx laboratory. Manager is responsible for day-to-day operational implementation of activities for Quality Assurance and Regulatory Compliance. Responsibilities include the management of quality system activities, to include but may not be limited to: Quality Event Management, Change Management, Risk Management, Audits (both internal and external) quality planning and improvement, quality monitoring and reporting, and quality system training to promote the company and department in achieving its goals. Responsibilities also include Regulatory-related activities such as management and oversight of regulatory filings and submissions. This position works closely and collaboratively with the other functional areas throughout the laboratory.
Basic Minimum Educational Qualifications:
Bachelor’s Degree in a Science-related field; advanced degree preferred.
Basic Minimum Qualifications:
A minimum of 5 years of quality experience within the clinical laboratory industry.
A minimum 3 years of technical laboratory experience in a regulated environment is also preferred.
A minimum of 5 years of experience with regulatory and/or accrediting agencies (e.g., FDA, ISO, CLIA) hosting/performing inspections, responses to regulators, etc.
Eurofins CellTx is an FDA-registered laboratory for screening human cells, tissues, and cellular- and tissue-based products (HCT/Ps). With certifications, licenses, or accreditations for CLIA, AABB, ISO 15189 and various state agencies, we are designed to provide critical testing support for cell and gene therapy-based products. Our comprehensive test menu supports these organizations from donor source to transplantable cell-based products. Our laboratory is located in Tucson, Arizona at the University of Arizona Technology Park.