The Director of Quality Assurance and Regulatory Affairs is responsible for leading the quality and regulatory functions at our Florida company locations. This position has the overall responsibility of managing our GMP, GXP quality systems and to maintain compliance with FDA Blood banking Regulations.
Manage the Quality Assurance in the development/revision and implementation of Standard Operating Procedures (SOPs) as required.
Ensure compliance (GMP, GXP) with appropriate SOP’s according applicable standards and regulations for blood banking.
Maintains and improves product quality by performing monitoring, process audits, investigation customer complaints, deviations, nonconformances, CAPAs license renewals and regulatory and contract reporting related to blood bank requirements..e.g. CLIA, AABB.
Support and lead QA / QC personnel for internal quality and external regulatory compliance.
Provide technical leadership of new and emerging global regulations
Interpret and effectively deal with complex regulatory issues across business units in support of local and corporate goals.
Act as a fully functional member of multi-disciplinary teams and provide expertise on regulatory matters.
Provide regulatory advice and perform regulatory assessments of business development opportunities
Benefits offered under an Individual Coverage Health Reimbursement Arrangement (ICHRA)
Blood Banking Regulatory or Similar: 3 years minimum