Site Data Integrity & Governance Leader

SHARP STERILE MANUFACTURING LLC; Lee (MA); On-site; USD 100,000 - 120,000; Full time

Job summary

SHARP STERILE MANUFACTURING LLC seeks a Senior Manager, Data Integrity & Governance to lead the site data integrity program at the Lee, MA facility. You will define ALCOA+ compliant policies, oversee risk-based assessments, and partner with IT, Manufacturing, Quality and Engineering to ensure cGMP compliance.

This role reports to the Site Quality Head and trains staff on data governance, audit trails, access controls, and validation of computerized systems.

Qualifications

• Minimum 5 years in data management and governance within pharma.
• Leadership experience in a pharmaceutical operation (1.5+ years preferred).
• Familiarity with ALCOA+ principles and regulatory guidance.

Responsibilities

• Lead site Data Integrity Management Program and define objectives.
• Serve as SME during inspections and audits; train personnel on ALCOA+ principles.
• Collaborate with IT, Manufacturing, Quality and Engineering to ensure data integrity compliance.
• Oversee risk-based assessments and remediation for computerized systems.
• Ensure cGMP data integrity across paper and computerized systems.

Skills

Data governance

ALCOA+

Regulatory compliance

GAMP5, 21 CFR Part 11

Project management

Cross-functional collaboration

Communication

Risk assessment

Leadership

Education

BS or higher in IT/engineering/science

Tools

Microsoft Office

Audit trails tools

Job description

SHARP STERILE MANUFACTURING LLC seeks a Senior Manager, Data Integrity & Governance to lead the site data integrity program at the Lee, MA facility. You will define ALCOA+ compliant policies, oversee risk-based assessments, and partner with IT, Manufacturing, Quality and Engineering to ensure cGMP compliance.

This role reports to the Site Quality Head and trains staff on data governance, audit trails, access controls, and validation of computerized systems.