Digital Quality Lead

As a member of the Quality organization, the R&D and PV Digital Quality Lead ensures robust quality oversight
of GxP‑relevant digital systems, with a particular focus on systems used in clinical activities. The role focuses on the
compliant implementation and ongoing control of computerised 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 computerised systems are fit‑for‑purpose, 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 decision‑making.

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 client 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 client -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 client's 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 computerised
systems.

• Bachelor’s Degree required, master’s degree preferred (IT, Engineering, Life Sciences, or related field).

• Prior experience in Pharmaceutical R&D with exposure to GxP computerised systems.

• Knowledge of GLP, GCP, GVP and GRA regulatory frameworks and associated
expectations for computerised 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