Job DescriptionPosition Purpose: Provide effective Quality support to ANZ Loan Kit & Set Creation Operations, Facilities (EFM), 3PL and other stakeholders to ensure J&J; products are stored and distributed with a high focus on Quality & Compliance, in order to meet the expectations of customers and patients.Key ResponsibilitiesLead the execution of Quality Management System elements applicable to DePuy Synthes National Warehouses, Loan Kits and Set Creation Operations in Australia/New Zealand, including the DePuy Synthes Loaner Standard.Ensure that products distributed by DePuy Synthes in ANZ are stored and distributed in accordance with applicable standards, and regulatory requirements, including: Handling, Storage & Distribution; Material & Product Controls; Temperature & Humidity Controls; Facilities, Utilities & Equipment Validation.Ensure that Johnson and Johnson storage facilities are designed, constructed, qualified, and maintained in accordance with applicable standards, product and regulatory requirements.Support Supply Chain related Facilities activities including new & changes to DC's, facility validation & mapping, maintenance & calibration, pest control & cleaning.Support equipment validation activities.Ensure effective quality management of Supply Chain & Facilities suppliers, including establishing & maintaining Quality Agreements, monitoring of change controls, NC's, & CAPA's, conducting or supporting audits, and responding to audit observations.Lead Quality activities for supplier engagement & disengagement.Support the response,



remediation & closure of audit observations for supplier audits.Support Supply Chain & Facilities related document (SOP's, WI's, etc.) development, reviews & provide Quality approvals.Provide leadership & guidance for the timely resolution & approval of NC's, CAPA's & Change Controls raised by Supply Chain and Facilities related to processes, equipment and facilities.Drive timely and effective resolution of Quality & Compliance issues relating to the distribution of DePuy Synthes products.Drive continuous improvements in DePuy Synthes Supply Chain Quality performance.Required QualificationsBachelor's degree required (Health, Science, Pharmacy, Engineering).
Minimum 5 years relevant experience in healthcare or related industry.Strong understanding of Quality requirements, systems and regulations.Deep understanding of ISO ****, ISO ***** and other international quality accreditation standards.Deep understanding of quality and regulatory requirements for medical device warehousing & distribution across Australia and New Zealand.Preferred SkillsAudit ManagementBusiness SavvyCoachingCommunicationCompliance ManagementContinuous ImprovementFact‐Based Decision MakingIssue EscalationProblem SolvingQuality Control (QC)Quality Management Systems (QMS)Quality StandardsRegulatory EnvironmentStandard Operating Procedure (SOP)Additional InformationLocation: North Ryde, Recent South Wales, Australia.
Job Category: Professional.
All job posting locations: North Ryde, New South Wales, Australia.
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📌 Commercial Quality Assistant Manager – Handling, Storage & Distribution (New South Wales)
🏢 7515-Johnson & Johnson MedicalLegal Entity
📍 New South Wales