Nikki Nelson
Loganville,MI
Summary
Results-driven and motivated Learning and Development professional with extensive industry experience in Computer System Validation (CSV). Proven success driving regulatory compliance, performing learning development, and managing validation practices, and skilled at project management, guiding and reviewing IT solution lifecycles. Scrum Master adept in system validation, defect management, and proficient in auditing, inspections, and user acceptance testing. Clear communicator who collaborates with peers, clients, and stakeholders to consistently achieve departmental and organizational goals.
Overview
18
18
years of professional experience
1
1
Certification
Work History
COMPLIANCE AND TRAINING SPECIALIST, SENIOR PRINCIPAL BUSINESS ANALYST
Boehringer Ingelheim
01.2017 - Current
- Collaborated with the compliance function to establish a framework ensuring quality oversight for the Global Facilities and Engineering department.
- Ensured compliant deployment of computerized systems, including IT automation platforms, mobile applications, and Cloud Computing (e.g., SAAS, PAAS, IAAS), in line with internal CSV framework and Quality Management System.
- Provided expert guidance on risk-based validation and qualification strategies, ensuring 100% compliance with GxP regulations across multiple regions through global SOPs and GxP-related training content.
- Established and maintains a global Single Point of Information (SPOI) platform dedicated to the improvement of the CSV strategy and methodology within the global quality management system.
- Prepared, coordinated, and presented CSV processes during audits and authority inspections (e.g., FDA, ANVISA, EMEA).
- Oversaw CSV-related projects, including the preparation and execution of training related to the global quality management system and CSV framework.
- Operated in an international environment, collaborating with global matrix organizations and local/regional sites.
- Managed and provided specialized support for Veeva Vault and ITEMS (SAP IT Electronic Management System).
- Specialized in developing comprehensive training materials and leading engaging training sessions focused on fostering collaboration and synergy within Computer System Validation roles.
- Led documentation, change, and training workstreams from Sanofi to Boehringer Ingelheim.
LEAD ANALYST, IT SERVICE MANAGEMENT
Merial Limited/Sanofi
08.2012 - 01.2017
- Maintained global electronic and manual document management processes and designed, implemented, and managed compliance documentation processes. Developed and maintained the Change Control SOP.
- Advised on and implemented new document management policies and classification systems.
- Conducted Quality Assurance reviews of IT project documentation.
- Coordinated and managed documentation exchanges during IT Audit engagements.
- Supported approximately 150 IT personnel globally with document development, review, approval, retention, and destruction.
- Led change management and training workstreams during the Merial to Sanofi integration.
- Managed the global change control system and process for IT solutions and services.
- Facilitated change coordination meetings among various stakeholders.
- Provided Quality Assurance oversight to ensure completeness and quality of change records.
- Addressed issues, redundancies, and errors in change controls.
- Developed and provided change control matrices to Senior Management.
- Administered the configuration management database (CMDB), including updates to Configuration Items (CIs).
- Created and managed custom queries and reports for users.
CUSTOMER CARE REPRESENTATIVE
Merial Limited
03.2007 - 08.2012
- Acted as a liaison between customers, sales force, logistics, and marketing by placing orders, detailing promotions, and ensuring accurate and timely shipment of orders.
- Maintained an accuracy rate of over 96% in processing returns, credits, and exchanges.
- Demonstrated strong leadership and interpersonal skills daily as part of the customer care team.
- Conducted new agent training for customer care representatives, inside sales representatives, and field sales reps.
Education
Bachelor of Science (B.S.) - Biology
The University of Georgia
AthensSkills
- Regulatory Compliance
- Computer System Validation Practices
- CAPA Investigations
- Project Management
- Documentation Management
- Agile Methodologies
- Quality Assurance
- Testing and Defect Management
- Scrum
- Learning management systems
- Training program development
- Training program design
- E-learning platforms
Certification
- ITIL Foundation Certification
- Professional Scrum Master I | Scrum.org
Timeline
COMPLIANCE AND TRAINING SPECIALIST, SENIOR PRINCIPAL BUSINESS ANALYST
Boehringer Ingelheim
01.2017 - Current
LEAD ANALYST, IT SERVICE MANAGEMENT
Merial Limited/Sanofi
08.2012 - 01.2017
CUSTOMER CARE REPRESENTATIVE
Merial Limited
03.2007 - 08.2012
Bachelor of Science (B.S.) - Biology
The University of Georgia
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