Data Integrity Program Lead Consultant

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.

With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Scope Clients Small Molecule Stability Team is looking for outside assistance with their Data Integrity planning and governance.

Consultant will support the labs Data Integrity transformation initiative through assessment, strategy development, governance implementation, and remediation planning. Activities may include Data Integrity maturity and risk assessments, data flow and process mapping, equipment and system evaluations, Annex 11 readiness reviews, governance framework development, and remediation roadmap creation.

Consultant will work collaboratively with site stakeholders to strengthen Data Integrity controls, improve inspection readiness, enhance laboratory system integration, and establish a sustainable site-level governance model aligned with regulatory expectations and industry best practices.

Core Experience 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 Regulatory Expertise FDA Data Integrity Guidance MHRA Data Integrity Guidance EU GMP Annex 11 PIC/S Data Integrity Guidance ALCOA+ principles GMP/GxP compliance requirements Laboratory Background Quality Control (QC) Analytical Development Stability

Laboratories Manufacturing Support Laboratories Key Skills Data Integrity assessments and risk evaluations Governance framework development Operating model design CAPA and remediation management Stakeholder engagement across Quality, IT, Laboratory Operations, and Manufacturing Inspection readiness and audit support Highly Desired Technical Experience LIMS: LabWare, LabVantage, STARLIMS Chromatography Data Systems (CDS): Waters Empower ELN: Electronic Laboratory Notebooks SDMS: Scientific Data Management Systems Computer System Validation (CSV) / Computer Software Assurance (CSA) ICH Q9 Risk

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