The Sr. Data Integrity Specialist will concentrate on delivering subject matter expertise in GxP (GMP and GDP) to ensure compliance with data integrity standards, supporting the Data Integrity Governance program through assessment/remediation activities and maintaining the Sharp US Commercial-wide Data Integrity governance system.
Requirements
- Possess advanced understandings of GMP and GDP regulatory requirements regarding drug, device, and drug-device combination products.
- Provide day-to-day support for the governance, management, coordination, and implementation of activities related to the Data Integrity activities across Sharp US Commercial sites and in alignment with relevant governmental regulations and guidelines.
- Responsible for developing, reviewing, and approving appropriate Sharp policies and procedures (including safety rules and regulations) and coordinating all relevant activities between Quality, IT and other departments in relation to implementation, maintenance and change management of assigned programs.
- Support and manage remediation efforts, utilizing Quality Risk Management (QRM) based principles to identify risk and establish appropriate prioritization.
- Provide active support during regulatory agency and third-party inspections.
- Support knowledge transfer and training to departmental team specific to data integrity requirements.
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
