Sterigenics Germany GmbH, part of Sotera Health Group, is the global leader in medical product sterilization. Our Wiesbaden site operates under the German Federal Immission Control Act (BImSchG) and employs around 110 staff members.
The Senior Quality Assurance Manager leads the quality assurance, audit readiness, and regulatory compliance oversight for Nelson Labs embedded laboratories across Sterigenics' global facilities. This role ensures alignment, standardization, and compliance with internal and external quality systems and accreditation standards, supporting scientific integrity, regulatory obligations, and business objectives.
Reporting Structure:
* Manager (solid‑line report): Senior Manager, Global Quality Compliance (Nelson Labs)
* Key partners (no reporting relationship): Director RA/QA, EMEAA (Sterigenics) and site Sterigenics leadership (e.g., Lab Managers / Operations leaders) for alignment on regulatory commitments, audit readiness, and site execution.
This is an independent role with primary accountability to Nelson Labs Global Quality and strong cross‑functional collaboration with Sterigenics RA/QA and site leadership. The role may have direct QA/quality supervisors at individual embedded lab sites reporting directly or in a matrix structure depending on site maturity.
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