GxP Data Integrity Lead

Sharp Services; Allentown (Lehigh County); On-site; USD 80,000 - 110,000; Full time

Job summary

Sharp Services is seeking a Sr. Data Integrity Specialist to ensure compliance with data integrity standards across its US Commercial sites. This role requires deep knowledge of GxP regulations, cross-functional collaboration, and strong project management skills. The candidate should possess an associate or bachelor's degree and a minimum of four years of Data Integrity experience, along with expertise in Quality Risk Management. The position involves substantial interaction with regulatory agencies and internal teams to enhance compliance and promote best practices.

Qualifications

• Minimum of four years of direct Data Integrity experience.
• Cross-functional experience in three or more areas in the pharmaceutical industry.
• In-depth knowledge of data integrity regulations and GxP CSV.

Responsibilities

• Manage Data Integrity activities across Sharp US Commercial sites.
• Support and manage remediation efforts using Quality Risk Management principles.
• Develop and review Sharp policies and procedures related to data integrity.

Skills

Subject matter expertise in regulatory requirements

Collaboration and cross-functional leadership

Project management skills

Strong interpersonal and communication skills

Education

Associate or bachelor's degree

Job description

Sharp Services is seeking a Sr. Data Integrity Specialist to ensure compliance with data integrity standards across its US Commercial sites. This role requires deep knowledge of GxP regulations, cross-functional collaboration, and strong project management skills. The candidate should possess an associate or bachelor's degree and a minimum of four years of Data Integrity experience, along with expertise in Quality Risk Management. The position involves substantial interaction with regulatory agencies and internal teams to enhance compliance and promote best practices.