Alkmini Sheehan

Background

About Alkmini Sheehan

25 years pharmaceutical industry experience. Forward-thinking, resourceful, and reliable Senior Quality Assurance Leader offering progressive experience driving Good Manufacturing Practice (GMP) and continuous improvement initiatives in the pharmaceutical industry. Highly organized and collaborative professional able to lead global cross-functional teams and cultivate strong partnerships with key stakeholders. Grasp the big picture, focus on details, and manage multiple priorities with efficiency, accuracy, and timeliness. Excel at analyzing all aspects of complex problems to craft solutions and execute corrective action. Committed to consistently exceeding expectations utilizing sound judgment, disciplined decision-making, sense of urgency, and personal accountability for results. APPLIED SKILLS & KNOWLEDGE QMS Development and Implementation ( Deviation/CAPA, Change Control, Batch Disposition, APR, Training, Audit, Complaints, Quality Agreements, and Sample Management) Change Control Management Annual Product Review (APR) CAPA Management Deviation Management Stability QA Approver Analytical QA Approver Biologics/Small Molecule/Oligonucleotide Product Complaint Management Product Disposition Process Improvement Contract Manufacturing QA Systems Integration IND/IMPD/NDA CMC Review Regulatory Compliance People Management Clinical Supply Clinical Manufacturing Commercial Supply Commercial Manufacturing Training Management