Senior Data Integrity Specialist
Not Disclosed•Full-TimeOn-site
location_onTwo City Center, 645, Hamilton Street, Center City, Allentown, Lehigh County, Pennsylvania, 18101, United States
About the Role
The Senior Data Integrity Specialist serves as a pivotal subject matter expert in GxP (GMP and GDP) standards, ensuring Sharp US Commercial operations maintain rigorous compliance with data integrity regulations. This role is central to the Data Integrity Governance program, driving assessment and remediation activities while managing the organization-wide governance system. The position exists to bridge the gap between regulatory requirements and daily operational practices, ensuring that all data handling processes meet both governmental guidelines and internal Sharp standards.
In this capacity, you will act as a strategic partner to Quality, IT, and commercial operations, developing and approving policies that govern data integrity. Your day-to-day involves coordinating cross-functional efforts to implement change management, utilizing Quality Risk Management (QRM) principles to identify and prioritize risks. You will also play a key role during regulatory agency and third-party inspections, providing active support and expertise. Beyond technical oversight, a significant portion of the role is dedicated to culture building—communicating data integrity principles and delivering training to individuals at all levels of the organization to foster a mindset of compliance and continuous improvement.
Work location
Work model: On-site
Two City Center, 645, Hamilton Street, Center City, Allentown, Lehigh County, Pennsylvania, 18101, United States
Allentown, Pennsylvania
Key Responsibilities
- check_circleDeliver subject matter expertise in GxP (GMP and GDP) to ensure data integrity compliance
- check_circleSupport the Data Integrity Governance program through assessment and remediation activities
Similar Job Opportunities
Skills, education and keywords
Skills: GMP, GDP, Data Integrity, Quality Risk Management, QRM, Computer System Validation, CSV, SDLC, Part 11.
Education: Associate's degree preferred; Bachelor's degree preferred.
Frequently asked questions about Senior Data Integrity Specialist at Sharp Services
What does a Senior Data Integrity Specialist at Sharp Services do?expand_more
Day-to-day, the Senior Data Integrity Specialist at Sharp Services will deliver subject matter expertise in gxp (gmp and gdp) to ensure data integrity compliance; support the data integrity governance program through assessment and remediation activities; provide active support during regulatory agency and third-party inspections; and maintain the sharp us commercial-wide data integrity governance system to meet regulatory requirements.
What are the requirements for this Senior Data Integrity Specialist role?expand_more
Sharp Services is looking for candidates who meet the following requirements: Associate or bachelor's degree preferred; Minimum 4 years direct Data Integrity experience; Pharmaceutical industry experience required; Knowledge of GxP (GMP/GDP) regulations; Knowledge of Part 11 requirements; and Knowledge of GxP Computer System Validation (CSV).
Where is the Senior Data Integrity Specialist role at Sharp Services located?expand_more
Senior Data Integrity Specialist at Sharp Services is based in Two City Center, 645, Hamilton Street, Center City, Allentown, Lehigh County, Pennsylvania, 18101, United States. This is a on-site role.