Overview
On Site
Full Time
Skills
Business Process
QA Management
Project Management
Management
Facilitation
Data Mapping
Requirements Elicitation
Data Flow
Leadership
Continuous Improvement
Regulatory Compliance
Vertex
Quality Assurance
Accountability
Computerized System Validation
Data Integrity
Medical Devices
GxP
GMP
GDP
GLP
Corrective And Preventive Action
Change Control
Risk Assessment
Epic
Quantitative Analysis
HL7
HIPAA
SOP
SQL
HTML
XML
Electronic Data Interchange
Silk
HP Quality Center
IBM
IBM Notes
JIRA
Confluence
Microsoft TFS
LIMS
Job Details
Responsibilities:
- Facilitate holistic data integrity reviews by partnering with QA and stakeholders to conduct end-to-end business processes assessments.
- Prioritize gaps and risks and provide oversight to needed remediation activities.
- Serving as a Strategic Quality Lead (providing project management, leadership, and participation) for DTE computerized system life cycle (SLC) activities for Vertex GxP systems.
- Managing and Facilitating Data Mapping initiatives for programs level processes.
- Providing Business Analyst skills and resources to projects across QA to facilitate requirements gathering, development of process/ data flow maps, and data integrity assessments.
- Authoring, reviewing, and approving work process documents (SOPs and Work Instructions).
- Generating and maintaining metrics for Quality Leadership Teams.
- Identifying and implementing continuous improvement opportunities.
- Leading oversight of electronic data integrity compliance guidance for Vertex GxP systems.
- Assessing emerging needs in the industry to identify technology/ skills gaps within the team.
- Coordinating with project stakeholders, GxP QA areas, and business representatives to ensure QISM is involved, informed, and accountable for Program activities and initiatives within the QISM scope.
- Identifying and implementing continuous improvement opportunities.
- Leading oversight of electronic data integrity compliance guidance for Vertex GxP systems.
- Assessing emerging needs in the industry to identify technology/ skills gaps within the team.
- Coordinating with project stakeholders, GxP QA areas, and business representatives to ensure QISM is involved, informed, and accountable for Program activities and initiatives within the QISM scope.
- Computer system validation, Data integrity, Medical device 510K, Predicate rules, ECTD,21 CFR Part 11, 210, 211, 312, 314, 820 GXP,GMP, GDP, GLP, CAPA, Change control, Risk assessment, Data base, Trail master file, EPIC system validation, Enrollment 834, Claims 837, Qualitative & Quantitative Analysis, HL7, HIPPA, SOP, SQL, HTML,XML, EDI, Silk, Client Quality Center, IBM Lotus notes, Jira Confluence, Microsoft TFS, LIMS.
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