QC System Integration and Validation Lead

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. Location

• Philadelphia, PA (if there is no 100% on site presence possible, a travel model can be suitable e.

g. every second week) A candidate whose background more closely aligns with laboratory instruments and systems is preferred.

Scope of Work:

Execution

• Implementation and Control This work package prepares the active implementation of the developed plan.

The objective is the on-time, on-budget, and high-quality implementation, validation, and go-live of the defined QC target systems based on the 4 packages (Implementation Kick-offs, Management and Oversight of Implementation, Continuous Progress Tracking,Support of Validation Activities) for each of the systems: SingleLIMS ChemiDoc-IT2 Imager NuGenesis

SDMS SDC

ViCell Blu 32-Karat Security Administration/VISIONsecurity ZS Xplorer Software/OmniTrust/OmniTrail QX Manager

• GxP LMS Xchange SoftMax Pro GxP (incl Admin)
• > gSMP Diomni QuantStudio Test Development Software WinKQCL Image Lab (ChemiDoc Gel Reader) gLabX Empower 3 Enterprise
• GMP•> gEmpower Raw 2.

0

Implementation Kick-offs:

Activity:

Conducting dedicated kick-off meetings before the start of each target system's implementation.

Deliverable:

A unified understanding, clear objectives, and binding commitment from all involved team members, subject matter experts, and users for their respective implementation phase.

Management and Oversight of Implementation:

Activity:

Actively managing and coordinating all technical and organizational implementation activities according to the project plan. This includes configuration, monitoring of master data migration, and steering of internal and external resources.

Deliverable:

The QC target systems are technically implemented and ready for the formal testing and validation phases. Continuous Progress Tracking (Controlling):

Activity:

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.

Deliverable:

Transparent Progress Reports for management and stakeholders. Ensuring the project remains "on track" or that deviations are managed in a controlled manner. Support of Validation Activities (Compliance):

Activity:

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).

Deliverable:

Successfully executed validation activities, which confirm compliance with internal (Roche) and external (e.g., GxP) regulations. This is the prerequisite for formal system acceptance and go-live.

Service Delivery & Project Management KPIs :

1. Delivery Speed (Velocity)

KPI:

Sprint/PI Commitment Completion What it measures: The percentage of items (Main Objectives, Team Tasks) successfully delivered compared to what was planned.

Target:

85%

• 90% completion of committed backlog items per cycle.

2. Quality of Execution (Defect Rate)

KPI:

Quality of Outcome What it measures: How many bugs or technical issues are found after the team says the work is done (e.g., during PQ runs or GMP phases).

Target:

Zero critical defects; < 5% minor issues. 3. Efficiency (Turnaround Time)

KPI:

Average Lead Time for Change Requests What it measures: The total time from when a user submits a request (e.g., a new equipment integration) to when it is fully tested and ready for use.

Target:

Consistent reduction in weeks/days over the project duration. 4. Reliability (First-Pass Success)

KPI:

Right-First-Time (RFT) Testing What it measures: The percentage of test cases or validation protocols that pass on the very first attempt without needing a "re-test" or software fix.

Target:

> 95% success rate for manual and automated tests. Kaleidoscope, an Infosys Company, is an equal opportunity employer, and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, spouse of protected veteran, or disability.