Site Data Integrity & Governance Leader

Sharp Services, LLC; Lee, Northern (MA, KY); Hybrid; USD 100,000 - 120,000; Full time

Job summary

Sharp Services, LLC in Lee, MA, is seeking a Senior Manager, Data Integrity & Governance to lead the data integrity program across the site, ensuring ALCOA+ compliance for GxP data in computerized and paper systems.

You will collaborate with IT, Manufacturing, Quality and Engineering to implement risk-based data integrity controls, train staff, and oversee regulatory inspections and client audits, driving continuous improvement.

Qualifications

• 5+ years of data management, governance and quality tooling experience.
• 1.5+ years in a leadership role within pharma operations preferred.
• Experience applying 21 CFR Part 11, EudraLex Annex 11 and GAMP standards.

Responsibilities

• Lead the Site Data Integrity Management Program and define objectives.
• Serve as SME during regulatory inspections and client audits.
• Collaborate with IT, Manufacturing, Quality and Engineering to integrate DI into governance.
• Oversee risk assessments, CAPAs, RCA and remediation activities.

Skills

Data governance

Leadership

Communication

Project management

Analytical thinking

Education

BS in IT/Engineering

Tools

Microsoft Office

Adobe Acrobat

GxP systems

Job description

Sharp Services, LLC in Lee, MA, is seeking a Senior Manager, Data Integrity & Governance to lead the data integrity program across the site, ensuring ALCOA+ compliance for GxP data in computerized and paper systems.

You will collaborate with IT, Manufacturing, Quality and Engineering to implement risk-based data integrity controls, train staff, and oversee regulatory inspections and client audits, driving continuous improvement.