Don Rackham
Quality Professional with 30 years of experience in complex biologic products
- Role
- Senior Director, Quality at Freenome
- Location
- Fremont, CA, US
- LinkedIn followers
- 500 followers
About Don Rackham
Accomplished quality professional with over 30 years of experience in the life sciences, clinical diagnostics, and pharmaceutical industries. Proven expertise in cell analysis methodologies and a deep technical foundation in quality management systems. Specialized in CMC development, risk-based quality management (QRM, QbD), and regulatory frameworks including ICH guidelines, ISO9001, ISO13485, ISO14971, and 21 CFR regulations (210/211, 600, 1271, 820). Extensive leadership, building teams and managing deviations, nonconformances, CAPA systems, supplier management, training programs, complaints, product development, and comprehensive risk management. Skilled in qualification and validation activities spanning facilities, equipment, processes, analytical methods, and computer systems. Certified Quality Auditor (CQA) and Six Sigma Green Belt (SSGB).
Experience
Senior Director, Quality
Aug 2022 — Present
Lead and mentor a cross-functional team of 12–20 staff, including directors, managers, and individual contributors, within a fast-paced diagnostics environment.Oversee quality assurance activities for the development and validation of blood-based cancer diagnostics, including Laboratory Developed Tests (LDTs) and In Vitro Diagnostics (IVDs).Ensure compliance with regulatory and quality standards (e.g, CLIA, CAP, FDA) across products utilizing next-generation sequencing (NGS), protein-based assays, and immunoassays.Drive continuous improvement initiatives and risk-based quality strategies to support innovation and maintain robust quality systems.Collaborate cross-functionally with R&D, regulatory, clinical, and operations teams to streamline quality processes and support product development lifecycle.
Education
San José State University
B.S., Molecular Biology, Geology
1989 — 1993
Skills
- Medical Devices
- Lifesciences
- Pharmaceutical Industry
- Quality System
- Fda
- Iso 13485
- Clinical Development
- Biotechnology
- Quality Assurance
- Product Development
- Life Sciences
- Cell Culture
- Technology Transfer
- Quality Control
- Strategy
- Manufacturing
- Commercialization
- Assay Development
- Six Sigma
- Risk Management
- Validation
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