Dan Reed Email & Phone Number

Following Instem’s acquisition of d-wise in March 2021, I’ve transitioned to the Governance, Risk Management and Compliance team.

Morrisville, North Carolina, United States

Quality Management Process improvements; Quality, Security and Compliance oversight; develop, implement, and maintain the Quality Management System; Quality System reviews, Corrective and Preventive Actions, training, internal auditing, and vendor management

Morrisville, North Carolina, United States

Senior IT and Validation for a global technology consulting organization specializing in data and SAS solutions. Design validation strategies for compliance with standard operating procedures, policies and regulations affecting final product integrity. Create validation documentation including Validation Plans, Risk Assessments, Requirements.

Raleigh-Durham, North Carolina Area

Validation and Testing Lead for projects leveraging the Oracle Argus Drug Safety platform. Execute on departmental initiatives to grow and mature testing and quality management capabilities. Provide technical and regulatory guidance to Test Managers, Test Leads and their teams on day-to-day basis. Lead and facilitate development of sound risk based test.

Raleigh-Durham, North Carolina Area

Lead role in the management of the global change control process for business and clinical information systems and the supporting infrastructure (servers, databases, and networks). Accountable for ensuring all systems are effectively tested before production release and remain in a validated state after maintenance, upgrades, changes and enhancements..

Raleigh-Durham, North Carolina Area

Key member of the Regulatory Information Systems Team responsible for delivering multiple IT projects with budgets up to $500,000. Accountable for the qualification, validation, implementation and administration of global content management systems providing secure storage for GxP documents. Contribute to risk and regulatory compliance assessments.

Raleigh-Durham, North Carolina Area

Global Regulatory Affairs Business Lead for the implementation and deployment of Documentum and Liquent EzSubs to support global product registrations including US, EMEA, APAC and LATAC regions. Provided application user support and maintained the system security configurations. Reviewed all system design specifications, requirements and validation.