Oversee embedded‑lab‑specific change control and document control (SOPs, protocols, manuals, validation records). * Participate in management reviews, quality reviews, program steering committees, and escalate risks appropriately. Regulatory Interface & Risk Management Management & Leadership * Collaborate closely with operations, lab management, regulatory teams, and global QA functions to align quality and operational goals. * Experience leading internal and external audits (customer, regulatory, and/or accreditation bodies) and managing quality event systems, including CAPA, investigations/deviations/nonconformances, and document control. Demonstrated ability to influence and drive quality improvements across stakeholder groups (Operations, Laboratory Management, Regulatory, and corporate Quality).
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