GxP Data Integrity Lead

Sharp Packaging Solutions, part of UDG Healthcare plc; Allentown (Lehigh County); In loco; USD 110.000 - 160.000; Tempo pieno

Descrizione del lavoro

Sharp Packaging Solutions, part of UDG Healthcare plc, seeks a Senior Data Integrity Specialist to ensure GMP/GDP data integrity and support governance across Sharp US Commercial sites. You will communicate data integrity principles and train staff at all levels within the organization.

Your role involves coordinating with Quality, IT, Regulatory, and Commercial functions to implement programs, manage remediation, and support inspections, with a focus on risk-based prioritization and continuous

Competenze

• BS/BA or higher with 4+ years in data integrity/QMS.
• Experience with regulatory filings and quality systems.
• Strong communication and training skills.
• Ability to coordinate across Quality, IT, Regulatory.

Mansioni

• Provide subject matter expertise in GMP/GDP data integrity.
• Support governance, management, and implementation across sites.
• Develop, review, and approve policies and procedures; coordinate between Quality, IT.
• Support remediation using Quality Risk Management principles.
• Assist during regulatory inspections.
• Deliver training on data integrity requirements.

Conoscenze

Regulatory compliance expertise

GxP Data Integrity

Cross-functional collaboration

Project management

Communication and training

Formazione

Bachelor's degree in related field

Descrizione del lavoro

Sharp Packaging Solutions, part of UDG Healthcare plc, seeks a Senior Data Integrity Specialist to ensure GMP/GDP data integrity and support governance across Sharp US Commercial sites. You will communicate data integrity principles and train staff at all levels within the organization.

Your role involves coordinating with Quality, IT, Regulatory, and Commercial functions to implement programs, manage remediation, and support inspections, with a focus on risk-based prioritization and continuous