Position Details: Argenx/Eli Lilly-Computer System Validation-GxP

Description:

Owns validation approach, risk assessment, scope, and testing strategy
using GAMP 5 / CSA principles to ensure effort is focused on patient
safety, product quality, and data integrity.

Manages validation deliverables, deviations, change control, CAPA support,
traceability, and audit readiness to maintain the validated state of
regulated systems.

Applies GxP expectations, GAMP 5 , and CSA guidance across traditional,
agile, and modern digital platforms, including knowing when supplier
documentation can be leveraged

Oversees validation of SaaS and cloud-hosted applications, including vendor
assessment, shared-responsibility understanding, release impact review, and
use of supplier evidence and quality agreements.

Ensures controls around audit trails, access, ALCOA+, data lineage, and
integrity risks across interfaces, manual processes, and connected systems.

Understands validation needs for AI/ML-enabled systems, including intended
use, data quality, explainability, drift monitoring, human oversight, and
revalidation triggers.

understanding of PV processes, system workflows, regulatory expectations,
documentation and support for validation lifecycle activities

Cloud platform knowledge, and underlying services/tech stack for
qualification, manages qualification deliverables, change control,
specifications, traceability to maintain the qualified state

Process knowledge of GxP frameworks and coordination across
applications/systems undergoing GxP validation activities; Experience with
IQ/OQ execution, user story creation, validation, testing, and change
management; Ability to drive stakeholder follow-ups and keep deliverables
on track; Training development and content authoring;

eLearning Platform Support: Hands-on experience with eLearning platforms;
Understanding of typical patterns and challenges in building and sustaining
these platforms from a project management perspective.

Perform an action: