Digital Quality Lead
Job Location:
Monthly Salary:
Posted on:
4 days ago
Posted on:
Vacancies:
1 Vacancy
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Job Summary
As a member of the Quality organization the R&D and PV Digital Quality Lead ensures robust quality oversight of GxPrelevant digital systems with a particular focus on systems used in clinical activities. The role focuses on the compliant implementation and ongoing control of computerized systems and associated data processes with particular attention to Computerized System Validation (CSV) and Data Integrity (DI) requirements. Working in close collaboration with various QA teams Clinical Operations and other stakeholders the Digital Quality Lead contributes to ensuring that all computerized systems are fitforpurpose validated and operated in accordance with global regulatory expectations and that data generated or processed by these systems meet the integrity and reliability standards required for regulatory decisionmaking.
MAJOR RESPONSIBILITIES
1. GxP System & Technology Compliance
Ensure GLP GCP GVP and GRA business systems are fully compliant with regulatory expectations (e.g. OECD ICH GVP) and UCB digital governance requirements.
Maintain and evolve the compliance framework for GxP-relevant systems (policies SOPs guidance).
Provide QA insight during system selection onboarding validation and ongoing oversight.
Support investigations deviations CAPAs and inspection-readiness activities related to DI or system failures ensuring completeness and alignment with regulatory expectations.
2. End-to-End Data Integrity (DI) Governance & Compliance
Ensure end-to-end Data Integrity across all GxP-relevant data flows from initial data capture in external partner systems through all transformations transfers and integrations into UCB-owned environments.
Work with Computer System QA team and Clinical Operations to ensure that DI controls (including ALCOA principles metadata management audit trails system-to-system data transfer checks and dataflow mapping) are embedded across the full data lifecycle.
Assess and document Data Integrity risks associated with externally operated systems and the interfaces linking them to UCB systems ensuring that controls are in place to protect data reliability and traceability.
Contribute to the development implementation and continuous improvement of DI practices aligned with ICH E6(R3) expectations and EMA guidance on sponsor oversight of computerized systems.
Requirements
Bachelors Degree required masters degree preferred (IT Engineering Life Sciences or related field).
Prior experience in Pharmaceutical R&D with exposure to GxP computerized systems.
Knowledge of GLP GCP GVP and GRA regulatory frameworks and associated expectations for computerized systems (e.g. OECD GLP ICH E6(R3) EU GVP Module I/IX).
Strong understanding of Computerized System Validation (CSV) principles including risk-based approaches and system lifecycle activities.
Hands-on experience in GPvP or GCP system validation.
Experience with data integrity requirements (ALCOA metadata audit trails dataflow controls) and regulatory expectations for end-to-end data governance.
Experience in managing deviations investigations and CAPA activities within at least one GxP domain.
Ability to assess external vendor systems for compliance validation status and DI risk including interpretation of validation packages and supplier documentation.
Ability to interpret complex data flows across external and internal systems and identify data integrity risks across the full lifecycle.
Strong critical-thinking and problem-solving skills with the ability to apply regulatory expectations to practical system scenarios.
Ability to work effectively with cross-functional teams to align expectations and ensure consistent compliance across shared system
Required Skills:
Responsible for overseeing the strategy governance and quality of all master data (Vendors Customers Materials) ensuring its accuracy consistency and alignment with business processes across the organization. Requirements: 10 years of experience in global data depth knowledge in Master Data Governance and Strategy Expertise in Data Quality Management knowledge in Data Integration and Architecture Change Management and Data Migration
