The Senior Quality Assurance Manager leads the quality assurance, audit readiness, and regulatory compliance oversight for Nelson Labs embedded laboratories across Sterigenics' global facilities. The role may have direct QA/quality supervisors at individual embedded lab sites reporting directly or in a matrix structure depending on site maturity. * Develop, maintain, and continuously improve the quality assurance framework applicable to embedded labs, aligned with Nelson Labs global quality policies and Sterigenics QMS. * Ensure that all embedded lab sites meet accreditation requirements (ISO 17025, GLP, GMP, and other relevant standards, customer, or regulatory audits). * Oversee embedded‑lab‑specific change control and document control (SOPs, protocols, manuals, validation records). * Assess regulatory risk and compliance impact when new testing scopes or upgrades are introduced in embedded labs.
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