Professional Summary

Strategic Motivational Leader – Strong cross-functional leadership and development skills spanning over 20 years leading departments, teams, and complex, high-profile projects.

Resource Management – People first approach to mentoring and training employees for best project outcome and alignment with industry compliance requirements.

Technical Management - Strategic risk-based management style to evaluate and implement innovative technologies and processes for feasibility and best fit for the organization. Proven track record resulting in increased effectiveness and efficiency.

Professional Experience

GLOBAL QUALITY AND COMPLIANCE CONSULTING, L.L.C.

Director Strategic Systems Planning April 2023 – February 2024

Ad hoc position spearheaded critical projects to ensure the optimal growth and sustainability of this start-up organization. Led a diverse range of focus areas, from strategic planning and resource management to implementing streamlined processes, conducting audits, mission critical documents creation and risk management protocols for biologic manufacturing organizations. Supporting clients in various stages of development (pre-clinical, GxP, clinical trials, inspection readiness, etc.)

INOZYME PHARMA, Inc.

Consultant – Senior IT Project/Quality Management July 2020 – March 2023

Pivotal role in developing and implementing Quality Management Office (QMO) and Quality Management System (QMS) initiatives.

Led system design, development, and configuration of 10 distinct modules tailored to organizational needs.

Developed training programs to ensure user competency and confidence in utilizing the system.

Implemented cross-functional analytics solutions for senior management.

Established system administration processes for improved efficiency.

iSTAFF

Consultant – Equifax April 2020 – April 2021

Senior Project/Program Manager leading cloud transformation efforts.

Collaborated with senior leadership and cross-functional teams to develop a strategic plan for migration to cloud infrastructure.

Implemented robust risk management strategies to mitigate potential challenges.

Designed and oversaw a multi-tiered incentive plan to align employee efforts with organizational goals.

BIOETHICA

Consultant October 2019 – July 2020

Collaborated with heads of quality and compliance in biotechnology and biopharmaceutical industries.

Built quality arm of business and provided strategic program management and systems management services.

Focused on QMS and QMO development, business continuity, disaster recovery, and process improvement.

BIOMERIEUX - VITEK

Consultant via Technology Partners June 2019 – October 2019

Functioned as Assistant Global Program Director/Project Management

Led cloud transformation of Internal Tools department including systems across multiple departments.

Formulated and implemented long-term plans for technological upgrades and improvement.

Managed resources identified and mitigated risks, and provided Agile coaching.

WASHINGTON UNIVERSITY SCHOOL OF MEDICINE – INSTITUTE FOR INFORMATICS

Consultant via Adaptive Solutions Group November 2018 – April 2019

Operations Manager, PMO Development, and Product Owner

Operations Manager and Product Owner of Research Electronic Data Capture (REDCap) system.

Led major version upgrades/migrations and developed roadmap for enhanced database monitoring, data center improvements, and data integrity.

Enhanced operational procedures and system management processes, resulting in increased productivity and communication.

Provided training on communication and Agile Scrum framework maturity.

Managed customer and vendor relations.

Involved in PMO development.

PATHEON BIOLOGICS/THERMO FISHER SCIENTIFIC

PMO Development Senior Project Manager August 2014- August 2018

Spearheaded PMO development for the St. Louis site and global problem-solving initiatives.

Trained cross-functional teams on Practical Process Management, Six Sigma, and Agile methodologies.

Worked closely with Head of Quality on compliance and regulatory initiatives.

Led projects in Systems Management, Supply Chain, Pre-Approval Inspection remediation, and application migrations.

Led Quality Control and Raw Materials remediations.

Led regulatory and organizational projects.

Drove collaborative consensus in intra and cross-functional efforts.

Researched and implemented innovative technologies and processes.

MAGELLAN HEALTH SERVICES, INC.

Project Management/Product Owner October 2007- August 2014

IT Service Management for MKS Application Lifecycle Management and Configuration Management System to collaboratively define product direction, technology enhancements, and create integrated solution-based processes for organizational initiatives.

Led initiatives to increase new business solutions and system/application usage meeting tactical and strategic enterprise needs through performance improvement and streamlined automated processes.

Developed and facilitated training for end users on project specific applications.

Led process and application evaluation, continuous process improvement, team/project budget, development, and risk management for compliance.

KELLY MITCHELL, INC.

Project/Business Manager and Mentor April 2006 – August 2007

Contract position with AT&T as Project/Business Manager for multiple complex projects, using Agile and other project management methodologies for Middleware group supporting various departments throughout the enterprise.

Lead Project Manager for Middleware group and a member of the organizational PMO for top tier initiatives.

Managed and mentored cross-functional department team members to increase their skills in line with organizational values and mission.

Oversaw all aspects of Middleware projects and teams to ensure deliverables completed in compliance with Federal, State, and Municipal regulations.

Skills and Related Experience

Project & Program Management: Risk based approach to Portfolio Management, Agile, Lean Six Sigma, and Waterfall Methodologies.

Strategic Planning: Business Strategy, Market Analysis, People Analytics, Competitive Intelligence

Quality & Compliance: Regulatory Compliance, Quality Assurance, Auditing, Remediation

Technical Acumen: Software Development and Configuration, Analytics, Cloud Computing, AI, Cybersecurity

Leadership & Collaboration: Cross-Functional Team Leadership, Stakeholder Engagement, Vendor Management.

Associations

Project Management Institute - Project Management Professional Number 2163222

Success Training Institute- Curricula completed; Management, Team Building/Conflict Resolution.

Executive Fellows Mentorship program at University of Missouri – St. Louis 2015

President Magellan Toastmasters 2014

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