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Summary:

The Data Governance consultant will provide support to the Data Governance Program Management Team by assisting in administrative tasks used to maintain the Data Governance Program e.g. creation of meeting presentations, and developing content based on current business events.

The Data Governance consultant provides administrative support of quality system records activities such as the creation and approval of change controls, risk assessments, corrective and prevention action plans (CAPAs), standard operating procedure (SOPs), work instructions/job aids, policies, process quality deviations etc.

Job Responsibilities include, but are not limited to, the following:

• Organize and Schedule Meetings with different teams
• Maintain email and distribution lists for different group
• Produce and Distribute Meeting Minutes on a regular basis
• Prepare and Maintain Monthly Metric based on Quality System Data
• Create Monthly PowerPoint Presentations for review by Data Governance Program Management Team
• Coordinate document workflows to support certain Quality Events
• Coordinate and route incoming Questions related to Data Integrity
• Update and maintain SharePoint pages used by the Data Governance Program Management Team

Experience:

• 3-5 years of experience working in an FDA regulated environment
• Experience with quality management systems including change control, incident management, and deviation management.
• Strong Project Management experience leading efforts requiring coordination between cross functional teams within at least one area of systems validation e.g., laboratory equipment, facilities, utilities, manufacturing equipment, information systems, etc.
• Continuously drive to improve processes for improved performance
• Excellent technical writing and communication skills
• Excellent analytical and problem-solving skills
• Basic knowledge of FDA CFRs, Eudralex, and other biotech/pharma industry regulations (pertaining to IT, laboratory systems, automation, and manufacturing)