Data Integrity Program Lead Consultant
About The Position
ProPharma is seeking a consultant to support a client’s Small Molecule Stability Team with Data Integrity planning and governance. The consultant will support the laboratory’s Data Integrity transformation initiative through assessment, strategy development, governance implementation, and remediation planning. Work may include Data Integrity maturity and risk assessments, data flow and process mapping, equipment and system evaluations, EU GMP Annex 11 readiness reviews, governance framework development, and remediation roadmap creation. The consultant will collaborate 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. ProPharma describes itself as a provider of consulting solutions across regulatory sciences, clinical research solutions, quality and compliance, pharmacovigilance, medical information, and R&D technology. The company states that it is committed to diversity, equity, inclusion, and equal employment opportunity. It supports remote working and encourages hires who live within a reasonably short commute of an office to work hybrid, as agreed with their manager.
Requirements
- 10+ years of experience in the 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 Data Integrity maturity, performing gap assessments, and executing remediation programs.
- Knowledge of FDA Data Integrity Guidance, MHRA Data Integrity Guidance, EU GMP Annex 11, PIC/S Data Integrity Guidance, ALCOA+ principles, and GMP/GxP compliance requirements.
- Laboratory background in one or more of the following: Quality Control (QC), Analytical Development, Stability Laboratories, or Manufacturing Support Laboratories.
- Skills in 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, and inspection readiness and audit support.
Nice To Haves
- Experience with LIMS platforms such as LabWare, LabVantage, or STARLIMS.
- Experience with the Waters Empower Chromatography Data System (CDS).
- Experience with Electronic Laboratory Notebooks (ELN).
- Experience with Scientific Data Management Systems (SDMS).
- Experience with Computer System Validation (CSV) or Computer Software Assurance (CSA).
- Experience with ICH Q9 Risk Management.
Responsibilities
- Support the client’s Small Molecule Stability Team with Data Integrity planning and governance.
- Support the laboratory’s Data Integrity transformation through assessment, strategy development, governance implementation, and remediation planning.
- Conduct Data Integrity maturity and risk assessments.
- Map data flows and processes.
- Evaluate equipment and systems.
- Perform EU GMP Annex 11 readiness reviews.
- Develop governance frameworks and remediation roadmaps.
- Collaborate with site stakeholders to strengthen Data Integrity controls, improve inspection readiness, enhance laboratory system integration, and establish sustainable site-level governance.
- Support inspection readiness and audits.
- Manage CAPA and remediation activities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
