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Sakara Digital logo representing consultants supporting pharma, biotech, med device, and other regulated industries with expert consulting in QMS, DMS, LMS and digital systems.

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Our People

Senior Experts, Deeply Committed

Each member of our team brings decades of experience and a genuine investment in your success.

Amie Harpe, Owner & Principal Consultant for Sakara Digital. Amie spent 23 years at Pfizer across Quality Operations and Digital Solutions, including a document management deployment reaching 65 sites and more than 22,000 users. She now leads AI foundation and roadmap engagements for pharmaceutical and biotechnology clients.

Amie Harpe

Owner & Principal Consultant

Amie spent 23 years at Pfizer across Quality Operations and Digital Solutions, including a document management deployment reaching 65 sites and more than 22,000 users. She now leads AI foundation and roadmap engagements for pharmaceutical and biotechnology clients, grounding AI readiness in the quality and validation discipline regulated environments require.

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Dina Mishina, Principal Consultant for Quality & Compliance with Sakara Digital. Dina specializes in validation, CAPA management, and quality culture transformation. With a background spanning biotech and medical devices, she helps organizations build durable compliance frameworks that scale with their growth.

Dina Mishina

Principal Consultant, Quality & Compliance

Dina specializes in validation, CAPA management, and quality culture transformation. With a background spanning biotech and medical devices, she helps organizations build durable compliance frameworks that scale with their growth.

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Jidesh Upendran, Technology & Digital Systems Lead with Sakara Digital. Jidesh leads digital transformation and systems integration projects, helping life sciences organizations modernize their quality infrastructure. His expertise spans eQMS platforms, data integrity, and validated software implementation.

Jidesh Upendran

Technology & Digital Systems Lead

Jidesh leads digital transformation and systems integration projects, helping life sciences organizations modernize their quality infrastructure. His expertise spans eQMS platforms, data integrity, and validated software implementation.

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David Reed, Strategic Advisory & Business Development with Sakara Digital. David is a business strategist and leader with deep expertise in sales, growth management, and open source innovation. His background spans consumer goods, health, pharmaceuticals, and IT, with a focus on scalable solutions and stakeholder alignment.

David Reed

Strategic Advisory & Business Development

David brings decades of executive experience in life sciences strategy, business development, and organizational growth. He advises clients on long-term quality strategy, partnership development, and scaling operations effectively.


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Kevin Jenkins, Business Development & Principal Consultant for Quality Operations with Sakara Digital. Kevin brings more than 40 years of pharmaceutical quality and operations leadership, including 36 years at Pfizer. His work focuses on quality systems, operational readiness, and inspection preparation for regulated manufacturing.

Kevin Jenkins

Business Development & Principal Consultant, Quality Operations

Kevin brings 40+ years of pharmaceutical quality and operations leadership, including 36 years at Pfizer where he held VP-level roles in Aseptic Quality and Established Products Quality Operations. He specializes in aseptic processing, validation, and operational excellence, and co-authored the CRC Press Handbook of Validation in Pharmaceutical Processes.

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Darrell Crane, Principal Consultant for Project & Program Management with Sakara Digital. Darrell brings 35+ years of IT project and program management experience across Astellas, Pfizer, Zoetis, and other global life sciences companies. His specialties include LIMS, CTMS, data platforms, and validated GxP applications.

Darrell Crane

Principal Consultant, Project & Program Management

Darrell brings 35+ years of IT project and program management experience, leading enterprise system implementations at Astellas, Pfizer, Zoetis, and other global life sciences organizations. His specialties include LIMS, CTMS, data platforms, and validated GxP applications delivered under disciplined SDLC practices.

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