Quality Systems Lead - QA/QC & Compliance (3-Shift)

Sanofi

Bolzano

On-site

EUR 50,000 - 80,000

Full time

6 days ago

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Job summary

Sanofi is seeking a Quality Assurance Specialist in Bolzano, Italy, to ensure product quality and regulatory compliance within the Manufacturing & Supply network. You will manage QA systems, inspections, deviations, and CAPA to support safe medicines at scale.

This hands-on role emphasizes end-to-end quality governance and continuous improvement across cross-functional teams. You will lead Quality Systems, Validation reviews, QMI ownership, and data integrity while enabling cross-functional

Qualifications

2–5 years of experience in QA/QC environments.
Experience in IPQA, Batch Record Review and Shopfloor Quality Governance.
B.Pharm or M.Pharm degree required.
3-shift work availability.

Responsibilities

Manage and coordinate Quality Systems and related QA activities.
Coordinate Subcontractor/Service Provider QA aligned with global standards.
Oversee validation and calibration document reviews.
Perform batch release support and respond to QP queries.
Lead cGMP document control and training coordination.
Act as Primary Process Owner for Quality Maturity Index and support SMS/HSE.
Oversee Site Master File, instrument checks, and documentation archiving.
In-Process QA tasks including Master Batch Records review and line clearance.
Temperature/Humidity mapping, hold time studies, and qualification focal points.
Quality oversight of shopfloor and routine production sampling.