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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, Managing Partner & Principal Consultant for Sakara Digital. Amie is an accomplished IT leader with expertise in GxP, DMS, and QMS. Known for delivering global quality solutions, she is passionate about mentoring and helping teams achieve their full potential.

Amie Harpe

Founder & Principal Consultant

Amie brings 20+ years of experience in pharmaceutical quality systems and regulatory compliance. She has led multi-site QMS implementations, audit readiness programs, and cross-functional training initiatives at global life sciences companies.

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Dina Mishina, Business Development Lead & Principal Consultant with Sakara Digital. With over a decade of experience managing global IT projects, Dina brings strategic focus and operational excellence to every engagement. She excels at aligning teams with business goals and translating customer needs into effective, efficient solutions.

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, Principal Consultant with Sakara Digital. Jidesh is a senior IT leader with deep expertise in life sciences, specializing in DMS and GxP systems. Known for leading global teams through complex implementations and building strong partnerships that drive lasting impact.

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 is a seasoned business strategist and leader with deep expertise in sales, growth management, and open-source innovation. With a background spanning CPG, health, pharma, and IT, he brings a sharp focus on scalable solutions, stakeholder alignment, and mission-driven execution.

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, 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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