Bishrut T.
Associate Director Global Quality and Compliance @Acadia Pharmaceuticals
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WORK HISTORY
Associate Director Global Quality and Compliance @Acadia Pharmaceuticals
Contributed to the build-out of a global PV Quality Management System by supporting deviation management, SOP governance, training development, and Veeva-based compliance monitoring to strengthen inspection readiness.• Enhanced inspection readiness by drafting SOPs, supporting self-assessments, incorporating regulatory intelligence, and assisting with SME coaching and mock inspection activities to identify and close compliance gaps.• Developed draft versions of the PV Quality Policy and Quality Manual to establish foundational governance and ensure alignment with US and EU regulatory expectations.• Supported audit and inspection readiness by drafting PV procedures, coordinating CAPA follow-up, and assisting with key regulatory deliverables, including training matrices and updates to the EU PV Master File.
EDUCATION
Caldwell University
Bachelor's degree
California State University-Dominguez Hills
Master's degree
ABOUT BISHRUT T.
Quality & Compliance leader with 15+ years of experience shaping and advancing global…
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