Data Integrity Transformation Lead

ProPharma Group; United States; Hybrid; USD 120,000 - 170,000; Full time

Job summary

ProPharma Group is seeking a Data Integrity Program Lead Consultant in the United States to guide DI strategy and governance across regulated laboratories. You will perform maturity assessments, map data flows, and develop remediation roadmaps aligned with FDA, MHRA, and EU guidance.

The role requires senior leadership of enterprise DI programs, collaboration with QA, IT, and manufacturing, and experience implementing DI controls and audit readiness.

Qualifications

• 10+ years in pharmaceutical, biotechnology, or medical device industries.
• 5+ years leading enterprise or site-level Data Integrity programs.
• Experience driving DI transformations within GxP-regulated laboratories.
• FDA/ MHRA/ EU GMP Annex 11 guidance familiarity.
• Strong data governance and remediation planning experience.

Responsibilities

• Assess Data Integrity maturity and perform gap assessments.
• Develop DI governance framework and operating model designs.
• Create remediation roadmaps and CAPA programs.
• Collaborate with Quality, IT, Lab Ops, and Manufacturing stakeholders.
• Support inspection readiness and audit activities.

Skills

Data integrity

Governance

Regulatory understanding

Stakeholder engagement

CAPA remediation

Inspection readiness

Tools

LIMS

CDS (Waters Empower)

ELN

SDMS

CSV/CSA

ICH Q9

Job description

ProPharma Group is seeking a Data Integrity Program Lead Consultant in the United States to guide DI strategy and governance across regulated laboratories. You will perform maturity assessments, map data flows, and develop remediation roadmaps aligned with FDA, MHRA, and EU guidance.

The role requires senior leadership of enterprise DI programs, collaboration with QA, IT, and manufacturing, and experience implementing DI controls and audit readiness.