Senior GxP Data Integrity & Governance Lead

Sharp Services, LLC; Allentown (Lehigh County); On-site; USD 80,000 - 100,000; Full time

Job summary

Sharp Services, LLC is seeking a Senior Data Integrity Specialist in Allentown, United States. This full-time position focuses on ensuring compliance with GxP standards and managing the Data Integrity Governance program across various Sharp US Commercial sites. The ideal candidate will have a strong background in regulatory requirements, quality assurance, and exceptional interpersonal skills. Responsibilities include developing policies, supporting regulatory inspections, and providing training on data integrity principles.

Qualifications

• Minimum four years of direct Data Integrity experience required.
• Experience in the pharmaceutical industry with regulatory filing knowledge.
• Ability to collaborate and lead cross-functionally.

Responsibilities

• Manage Data Integrity governance activities across Sharp US Commercial sites.
• Develop and review Sharp policies and procedures related to Data Integrity.
• Support regulatory agency inspections and provide training.

Skills

GMP and GDP regulatory knowledge

Documentation skills

Interpersonal skills

Organizational and planning skills

Critical thinking

Project management

Education

Associate or bachelor’s degree

Job description

Sharp Services, LLC is seeking a Senior Data Integrity Specialist in Allentown, United States. This full-time position focuses on ensuring compliance with GxP standards and managing the Data Integrity Governance program across various Sharp US Commercial sites. The ideal candidate will have a strong background in regulatory requirements, quality assurance, and exceptional interpersonal skills. Responsibilities include developing policies, supporting regulatory inspections, and providing training on data integrity principles.