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. * 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. * Act as a quality with regulatory affairs, customers, accreditation bodies, and regulatory agencies. * 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.
mehr