Michelle Bachir Wright

Background

About Michelle Bachir Wright

For the past 15+ years, I have implemented practical, risk-based IT compliance solutions at global life science companies. I have an in-depth understanding of current GxP regulations and industry best-practices, and I am a PMI certified Project Management Professional (PMP). My experience includes having worked with many cross-functional, multi-cultural, matrixed teams, comprised of team members in up to 4 international time zones. I have led the compliance efforts on both large and small projects, ranging from the implementation of large, global enterprise-wide solutions to updating small stand-alone systems and from the buildout and commissioning of a new data center to the qualification of individual pieces of hardware. In my quality roles, I provided quality oversight to IT and have had responsibility for Quality management systems (QMS), learning management systems and deviation management. I am passionate about developing, mentoring, promoting and retaining talent. Additionally, as a lifelong learner, I enjoy reading and continually enhancing my skills. I particularly enjoy books on leadership and relationship building. Some of my favorite books include How to Win Friends and Influence People, Never Split the Difference and Confidence Code. Specialties: • Software and Computer Systems Validation (GAMP 5) • Risk Management: Risk Assessments, Vendor Audits, Internal Audits, Periodic Reviews, Gap Analysis • Quality Management Systems (QMS): Development, Implementation, Training, Management and Retirement • Project Management (PMP from PMI) • Associate White Belt Veeva Vault Platform • Regulatory Compliance: Gxp (GMP/GLP/GCP), 21 CFR Part 11, 21 CFR Part 820, Annex 11 • Testing: HPALM, Automated Testing, Testing Management • Change Control/ Change management • Process Improvement • Data center: Hardware Qualification, Data Center Build-Out and Qualification, Disaster Recovery • Deviation Management: Deviations, Defects, Corrective and Preventative Actions (CAPA) • Software Development Life Cycle Deliverables: Requirement Specifications, Validation Plans, Data Migration, Test plans, Validation Reports