Data Integrity Lead
Data Integrity Lead
Location: Sweden (Hybrid) Contract Length: 6 Months Initial (Extension Likely) Travel: Required across Nordic/European sites as needed Industry: Pharmaceutical / Biotechnology Manufacturing Start Date: ASAP
Overview
We are supporting a global pharmaceutical organisation seeking an experienced Data Integrity Lead to drive and oversee Data Integrity (DI) activities across GMP-regulated operations. This is a strategic and hands-on role leading a small team while collaborating closely with Quality, Manufacturing, Engineering, IT, Validation, and Regulatory functions.
The successful candidate will be responsible for strengthening the site's Data Integrity framework, ensuring compliance with global regulatory expectations, and supporting inspection readiness initiatives across multiple business areas.
This position operates in a hybrid model with periodic travel to manufacturing and operational sites.
Key Responsibilities
- Lead and coordinate Data Integrity programmes across GMP-regulated environments.
- Manage and mentor a small team of Data Integrity specialists.
- Develop and implement Data Integrity strategies aligned with regulatory expectations and company standards.
- Conduct Data Integrity risk assessments across systems, processes, and records.
- Drive remediation activities resulting from audits, inspections, assessments, and gap analyses.
- Partner with Quality Assurance, CSV, Automation, Manufacturing, Engineering, and IT teams to ensure compliant data lifecycle management.
- Review and approve Data Integrity documentation, investigations, CAPAs, procedures, and assessments.
- Support internal audits, regulatory inspections, and customer audits.
- Ensure compliance with ALCOA+ principles and current regulatory guidance.
- Provide subject matter expertise for computerised systems, electronic records, audit trails, and data governance.
- Deliver Data Integrity training and coaching throughout the organisation.
- Track programme metrics, identify compliance risks, and drive continuous improvement initiatives.
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