Iridium Biosciences   

Linda Lemieux, ALM.  

Independent Regulatory Compliance Consultant LinkedIn Profile

LLemieuxQuality@aol.com

              Linda Lemieux has worked in the field of quality and regulatory compliance for 15 years.  She has diverse Quality Assurance, Quality Control, and Regulatory Affairs experience with the ability to initiate and develop comprehensive quality programs based on regulatory requirements (including GMP, GLP, GCP, GTP, various ISO regulations, and ICH guidance documents).  She possesses an in-depth, working knowledge of the regulations and industry standards with the ability to develop or update systems for compliance.  She can carefully craft systems to be in harmony with clinical or commercial production keeping in mind the different business needs, sizes, and objectives.  She has the ability to communicate effectively with regulatory reviewers and inspectors and can perform PAI readiness or vendor audits.  Linda also has the ability to review validation documents, prepare Quality Manuals and Quality Reviews, performFMEA/risk analysis, and evaluate raw material testing programs.  She has a Bachelor’s Degree from Merrimack College in Biology and a Master’s Degree from Harvard University in Biological Sciences.

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