Wasim S.
Director Quality Data Integrity Digital Systems @ Vertex Pharmaceuticals
- Role
- Director - Quality Digital Systems Cmc Small Molecule at Vertex Pharmaceuticals
- Location
- Lexington, MA, US
- LinkedIn followers
- 500 followers
About Wasim S.
Director Quality Data Integrity for Digital Systems for a Life sciences company. Experience with Data Integrity regulations associated with FDA, MHRA and EMA. Strategic oversight of digital systems based on risk to Product Quality, Patient Safety and Data Integrity Experience providing Quality oversight for systems used in GMP / GDP / GVP and Enterprise systems.
Experience
Director - Quality Digital Systems Cmc Small Molecule
Oct 2021 — Present · Boston, MA, US
Lead the Quality team on DI programs and ensure underlying activities are conducted using GxP aligned risk- based methodologies that assure adherence to applicable regulations, industry standards, and Vertex policies, procedures and quality standards as set forth in the Quality Management System. Develop and implement a phase appropriate, GxP aligned risk framework that will ensure consistent, efficient, and sustainable processes for data integrity assurance. Develop global Data Integrity (DI) standards that are company-wide and impact all GxP areas, including technology vendors and CxOs, and ensure comprehensive cross functional collaboration and broad-based risk and impact assessments.
Education
M.S. Ramaiah Institute Of Technology
B.E, Industrial Engineering and Management
1993 — 1997
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