Michele Carter, Pmp Email & Phone Number

Hudson, Massachusetts, Us

Paris, France, Fr

Managed the QC Excellence PMO, providing oversight for quality control related projects across 76 sites, as well as governance meetings for senior leadership/sponsors report-outs. • Developed QC Network: Organize and facilitate QC Network meetings focused on specific relevant topics and sharing knowledge. Increased participation in meetings by 10% and provided opportunities for sites to highlight accomplishments and share knowledge.• Established Professional Development program. Surveyed team to understand desired skills. Developed a training program designed for upskilling team and preparing for the future needed skills.• Created new SharePoint site. Developed from scratch new QC Excellence SharePoint with goal of improving communication and knowledge sharing. New site launched Q4 2022.• Created new QC Excellence Yammer page to communicate events and projects, as well as promote site-to-site collaboration.• Identified QC Scheduling core solution. Partnered with vaccines business unit to determine user requirements, identify solutions, conducted POCs, and make proposal. Successfully identified Smart-QC as the preferred business solution in <6 months; sites now implementing.• Established new ALCM Tier I group. Facilitated the formation of the top-tier organization that will harmonize processes across QC sites and provide overarching support to the working groups.

Paris, France, Fr

Supported the Analytical Lifecycle Management Program. Led multiple product working groups. Performed gap assessments.• Managed the LiveLink migration project. Managed migration of over 2200 ALCM files into new documentation repositories with support from IT.• Implemented Fit4/SMS process. As change agent, developed visual capacity management board and KPIs for continuous process improvement. Established digital iObeya boards to replace physical ones.• Developed training programs. Planned and facilitated a 2-day workshop to develop a shared process for use by five sites to ensure business continuity. Developed new business process document. Participated in identification of a more appropriate inventory management tool, TRXio. Successfully implemented TRXio at 4 locations.

Westborough, Ma, Us

Responsible for overall chapter operations, as well as alignment with the strategies of the global organization.• Launched “Give Back” pilot program to provide chapter members opportunity to improve their own branding and develop soft skills.• Promoted professional development opportunities (e.g., Leadership Institute meetings, PMP exam prep)

Bridgewater, New Jersey, Us

Managed several remediation initiatives supporting the ongoing consent decree work.• Managed Steam-in-Place Process Qualification. Collaborated qualification executions with a cross-functional team. Successfully passed verification December 2015.• Managed Consent Decree Documentation Remediation. Managed the updating of 500+ documents from draft through approvals in 8 months working with a cross-functional team. Successfully passed verifications March and September 2015.

Hired to implement Quality Management System and provide oversight of contract manufacturer, as well as establish Project Management practices for this start-up company.• Built out a specialized BL2 blood lab/office. Led project from concept to completion. Enabled in-house testing, strengthening quality control, and reduced testing costs.• Established new Quality Management System (QMS). Developed and implemented the quality manual, quality statement, and all required documents to ensure QMS compliance to ISO 13485 and 21CFR820 regulations. Enabled NHSi to bring product development in-house.• Managed contract manufacturer relationship

Bridgewater, Nj, Us

Managed 3 engineers, R&D device builds and testing, as well as ensured reports generated. Led the biocompatibility and sterilization initiatives to support the 510k submission.• Led R&D project to cut costs for an innovative insulin product. Led project that identified several highly effective candidates; one provided a 5% cost advantage. • Established the Biocompatibility and Sterilization verification process required for the 510k submission of the V-Go Insulin Delivery System. Product achieved 510k approval. • Engineered process improvements. Collaborated with engineers and technicians to revamp key steps.

Bridgewater, Nj, Us

Managed all administrative functions, including operations, IT, HR, telecommunications and accounting.

Production Supervisor, Qualex division of Kodak, a photographic processing laboratory business unit. Managed production operations, quality, IT, accounting and administration. Directed a staff of 25.

Master'S Degree, Project Management With A Concentration In Clinical Trial Designs

Bachelors, Business Administration