Ronay Leblanc Email & Phone Number

Rochester, Ny, Us

Rochester, New York Metropolitan Area

NGT BioPharma Consultants offers a bespoke consulting model, ranging from a single SME to a full cross-functional team, which provides strategic and operational consulting services spanning all phase of drug development. The Quality & Compliance Service Area provides fit for purpose quality systems and services which include:- Full service GXP Quality Assurance function (Quality Unit) for organizations- Quality Management System (QMS) design, implementation, and operation- Vendor qualification and management, including assessments, audits, Quality Agreements, and performance monitoring- Clinical and commercial batch review and certification- GXP auditing, including inspection readiness and regulatory action response activities- Electronic record/signature compliant Electronic Document Management System (EDMS) for client use

Groton, Ct

Position was Assistant Vice President, Chemical and Pharmaceutical Development (CPD), Quality and Compliance, Wyeth Research prior to the acquisition of Wyeth by Pfizer in October 2009. This role continued through decommissioning completion of legacy CPD operations at end-2011. Then served in an interim position assisting with Pfizer Pharmaceutical Sciences Quality Assurance operations until retirement from Company end-July 2012. Responsible for leadership of the Good Manufacturing Practices (GMP) quality and compliance systems, functions, and staff of the (legacy) Chemical and Pharmaceutical Development (CPD) Department of Wyeth Research engaged in small molecule product development on a global basis. This includes responsibility for the quality assurance and compliance systems and functions at all legacy CPD sites (6 sites in the U.S., Canada, and UK), as well as oversight for the GMP quality and compliance of services provided by external manufacturers, packagers, testing laboratories, and other third party providers. Serves as the final authority with regard to the release and use of all investigational materials for human use produced and/or distributed by the Department on a global basis. Functional areas within the group include:• Quality Assurance units (4 units - U.S., Canada, and UK)• GMP training program• Procedures system• Validation/qualification systems, including equipment/instruments, facilities, utilities, methods, and processes• Change Control systems• Investigation and Product Complaint systems• Sustainable Compliance and Continuous Improvement programs, including Consent Decree remediation and certification activities• Information Services functions (i.e., technical document and regulatory submission processing, electronic document management, records management)• Project Team representation

Responsible for leadership of compliance and operations systems and functions (~40 staff) of the Chemical and Pharmaceutical Development Department (~700 staff) engaged in small molecule product development and clinical trial material manufacture on a global basis (6 sites in the U.S., Canada, and UK). Functional responsibilities within the group included:• GMP training and procedure systems• Sustainable Compliance program• Consent Decree remediation and certification activities• Part 11 computer system remediation program• Information Services functions (i.e., technical document and regulatory submission processing, electronic document management, records management)• Operations functions including project coordination, budgeting and staffing

Ma, Liberal Studies - Administration/Leadership

Ba, Biology/Microbiology