QC System Integration and Validation Lead

INFOSYS NOVA HOLDINGS LLC•Thornbury Township, PA

7h•Hybrid

About The Position

This role focuses on the execution and implementation of a developed plan for the on-time, on-budget, and high-quality implementation, validation, and go-live of defined QC target systems. The work involves managing and coordinating technical and organizational implementation activities, configuration, monitoring master data migration, and steering internal and external resources. A key aspect is continuous progress tracking, comparing plan vs. actual for schedule, cost, and scope/quality, and initiating corrective measures. The role also provides functional and coordinative support to the Quality Assurance (QA) team during validation activities (IQ/OQ/PQ) to ensure compliance with internal (Roche) and external (e.g., GxP) regulations, which is essential for formal system acceptance and go-live. The position requires a candidate with a background that aligns with laboratory instruments and systems.

Requirements

Must be authorized to work for ANY employer in the U.S.
Background more closely aligns with laboratory instruments and systems is preferred.

Responsibilities

Conducting dedicated kick-off meetings before the start of each target system's implementation.
Actively managing and coordinating all technical and organizational implementation activities according to the project plan.
Configuration, monitoring of master data migration, and steering of internal and external resources.
Persistent "Plan vs. Actual" comparison of project progress regarding schedule, cost, and scope/quality.
Early identification of deviations and proactive initiation of corrective control measures.
Providing functional and coordinative support to the Quality Assurance (QA) team during the planning, execution, and documentation of required validation steps (e.g., IQ/OQ/PQ).

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