Avani MacWan
Account Manager, Life Sciences @USDM Life Sciences
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WORK HISTORY
Account Manager, Life Sciences @USDM Life Sciences
At USDM, I advise and support Life Sciences companies in reimagining compliance as a catalyst for innovation. My role spans implementation, validation, and transformation initiatives, with experience in:Cloud-based systems: Box GxP, Salesforce, DocuSign, Oracle SCM, Microsoft 365, AWS, AzureQuality & training systems: Veeva QMS, ComplianceQuest, ComplianceWire, SAP, LMS365Clinical trial systems: eTMF, EDC, CTMS, Medidata, Oracle Clinical, LIMS, ArgusRegulatory systems: Veeva RIM, OpenText, Documentum, SharePointInfrastructure & access: Okta, ServiceNow, Azure Active DirectoryI work closely with stakeholders to align solutions with business goals and compliance requirements—whether it’s a Box validation for a Phase 2 biotech or a fully integrated Veeva-Vault-to-QMS program for a commercial MedTech.
EDUCATION
Sardar Patel University
Master's degree, Biochemistry
Sardar Patel University
Bachelor’s Degree, Biotechnology
ABOUT AVANI MACWAN
I help Life Sciences organizations—particularly emerging and pre-commercial biotech companies across the U.S. and Canada—navigate complex compliance and digital transformation challenges to accelerate innovation, commercialization, and operational efficiency.As part of USDM Life Sciences, I work with some of the most regulated environments in Pharma, Biotech, MedTech, and CROs, enabling them to modernize without compromising compliance. By aligning cloud technology with regulatory frameworks like FDA 21 CFR Part 11, EU Annex 11, ICH GCP, ISO 13485, and HIPAA, I deliver scalable strategies that reduce risk and deliver measurable outcomes. Key Focus Areas:Enabling compliant cloud adoption and digital transformation with systems like Box GxP, Salesforce, DocuSign, Oracle SCM, AWS, Azure, Google Cloud, and more.Validating and optimizing GxP-critical systems, including:Quality & Learning: Veeva QMS, ComplianceQuest, ComplianceWire, MasterControl, SAP, LMS365Clinical & Safety: Medidata, Oracle Clinical, eTMF, EDC, CTMS, LIMS, Argus SafetyRegulatory & EDMS: Veeva RIM, OpenText, Documentum, SharePointInfrastructure & Integration: Okta, ServiceNow, Microsoft 365, Azure ADDelivering continuous compliance and lifecycle management with Cloud Assurance (CAaaP), automated validation, and Computer Software Assurance (CSA) methodologies.Supporting clinical audit readiness, including PAI, GCP/Supplier audits, and Drug Accountability.Leading data strategy and governance to ensure integrity, traceability, and analytics readiness across structured and unstructured datasets. Let’s connect to drive innovation with confidence. Reach me at: a••••••@usdm.com
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