Data Integrity Program Lead - DI Transformation & Governance

ProPharma; Raleigh (NC); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Hybrid work model

Equal Opportunity Employer

Job summary

ProPharma seeks a seasoned Data Integrity consultant to advance governance and DI maturity across regulatory-lab environments. The role focuses on strategy, assessment, and remediation planning within GxP labs, collaborating with Quality, IT, and Manufacturing teams.

Ideal candidates will have 10+ years in pharma/biotech, 5+ years leading DI programs, and a proven track record in DI transformations, gap analyses, and remediation programs in regulated settings.

Qualifications

• 10+ years in pharmaceutical, biotechnology, or medical device industries.
• 5+ years leading enterprise or site-level Data Integrity programs.
• Experience driving Data Integrity transformations within GxP-regulated laboratories.
• Proven track record assessing DI maturity, performing gap assessments, and executing remediation programs.

Responsibilities

• Lead Data Integrity assessment, strategy development, governance implementation, and remediation planning.
• Collaborate with site stakeholders to strengthen DI controls and strengthen inspection readiness.
• Develop governance framework and operating model for DI program across Quality, IT, and Lab operations.
• Oversee CAPA processes and remediation activities while ensuring regulatory alignment.

Skills

Data integrity assessments

Governance framework design

Operating model design

CAPA & remediation management

Stakeholder engagement

Inspection readiness & audit support

Tools

LabWare

LabVantage

STARLIMS

Waters Empower

CSV/CSA

Job description

ProPharma seeks a seasoned Data Integrity consultant to advance governance and DI maturity across regulatory-lab environments. The role focuses on strategy, assessment, and remediation planning within GxP labs, collaborating with Quality, IT, and Manufacturing teams.

Ideal candidates will have 10+ years in pharma/biotech, 5+ years leading DI programs, and a proven track record in DI transformations, gap analyses, and remediation programs in regulated settings.