Ensure that all embedded lab sites meet accreditation requirements (ISO 17025, GLP, GMP, and other relevant standards, customer, or regulatory audits). * Lead and coordinate internal and external audits (customer, regulatory, certification bodies) and oversee timely closure of findings and CAPAs. * Participate in management reviews, quality reviews, program steering committees, and escalate risks appropriately. Regulatory Interface & Risk Management * Act as a quality with regulatory affairs, customers, accreditation bodies, and regulatory agencies. 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, ...
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