Alfredo Canhoto

About Alfredo Canhoto

Alfredo J. Canhoto is Senior Quality Assurance Leader at Alnylam Pharmaceuticals and has spent his career in the Biotech and Life Sciences field. As a biopharma validation expert, he drives compliance & operational excellence. In the biopharmaceutical quality & validation space, Alfredo helps companies achieve regulatory compliance & optimize operations. Alfredo has also served as a director-level consultant & speaker, elevating biopharma quality operations, validation & program implementation.My experience is in the Quality Assurance (QA), Validation, GxP (especially GMP), GMP Compliance, Process Validation, Equipment Validation, Cleaning Validation, Risk Assessment / Risk Management, Corrective and Preventative Actions (CAPA), Change Control, Audit Readiness, SOP Development, ICH Guidelines (especially ICH Q7, Q8, Q9, Q10), 21 CFR Part 11 Compliance, Regulatory Review, Investigations and Quality Systems.I have worked in both large and small Biopharmaceuticals, Biotech, Pharmaceutical Manufacturing, cGMP Facilities, FDA-regulated, EMA Compliance, Parenteral Manufacturing, Aseptic Processing, Biologics, and Monoclonal Antibodies (mAbs).I have experience working with Trackwise, Veeva Vault QMS, LIMS, and EDMS.

Experience

1. Director of Quality Assurance Operations

   ITF Therapeutics LLC

   Nov 2025 — Present · Concord, MA, US

   Lead daily Quality operations activities ensuring product quality and patient safety at each step within the supply chain- Review and approval of product related records and data based dispositions- Extensive engagement with suppliers and contract service providers throughout the supply chain network to achieve goals within compliance and regulatory requirements.

Education

• University of South Carolina

  Ph.D., BioChemistry

  1992 — 1997

• Dana-Farber Cancer Institute; Harvard Medical School

  Post Doctoral Fellowship, Cell/Cellular and Molecular Biology

  1998 — 2000

• University of Massachusetts Amherst

  BS, BioChemistry

  1988 — 1992

Skills

• Purification
• Manufacturing
• Chromatography
• Software Documentation
• 21 Cfr Part 11
• Root Cause Analysis
• Cell Culture
• Trackwise
• Quality System
• Quality Systems
• V&V
• Document Management
• Gamp
• Cleaning Validation
• Process Validation
• Laboratory
• Biopharmaceuticals
• Technology Transfer
• Glp
• Validation
• Gxp
• Lims
• Aseptic Processing
• Quality Control
• Gmp
• Qc
• Commissioning
• Capa
• Vaccines
• Cross-Functional Team Leadership
• Biotechnology
• Pharmaceutical Industry
• Sop
• Fda
• Cgmp
• Quality Assurance
• Change Control
• Computer System Validation