Quality and compliance leader with experience in QMS implementation, sterile operations, oral solid dosage/semi-solids manufacturing/R&D, regulatory inspections, auditing, and global IT system implementations. My career has been focused on implementing quality systems using a risk-based approach that ensure the delivery of high quality medicines.• Recognized leader in QMS implementation and management: deviations, non-conformances, laboratory investigations, customer complaints, CAPA and internal/external audit.• ASQ Certified (CQA) and experienced in GMP inspection and audit environments, including conductingexternal audits and hosting regulatory inspections (ex. FDA, PMDA, EMEA).• Proven ability to lead teams under pressure, examples include during warning letter remediation at Teva Irvine and FDA inspections.• Most recently, I have leveraged my quality experience in the development, deployment, and training ofseveral global IT systems (Sparta TrackWise and SAP Quality Management - QM), with a focus on meeting end-to-end business needs and CFR Part 11 compliance.