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Kenvue · 1 day ago

Manager Distribution Quality & Compliance

Mooresville, IN

Full-time

Onsite

Mid, Senior Level

$124K/yr - $175K/yr

6+ years exp

Kenvue is a company dedicated to delivering everyday care through its iconic brands. The Manager of Distribution Quality and Compliance oversees the Quality Management Systems to ensure compliance with laws and regulations at the Distribution Center, while driving innovation and managing partnerships to resolve quality-related issues.

LifestylePersonal HealthWellness

Responsibilities

Oversight of process and systems related with cGMPs, Product handling and storage, quality investigations and managing partnerships with 3PLs, Franchises and Affiliates. Serve as single point of contact to internal and external partners on Distribution Quality related matters to drive timely resolution of Quality related issues

Must be a strong leader to support 24/7 operations of the Distribution Center who is continuously working to improve quality, cost and time factors, consistent with both Sector and Commercial Quality business objectives

Responsible for Quality oversight to the receiving process within the DC as well as dispositioning of damaged packages (incoming) according to procedures or predefined agreements with Source co., Franchise, or Marketing Co. Responsible for Quality oversight in the followings: monitoring of product destruction process, quarantine/hold/stop-ship/recall processes within the DC and in pick/pack/and ship operations, including trending of pick/pack/ and ship errors

Responsible for ensuring returned product is dispositioned according to procedures or predefined agreements with Source co., Franchise, or Marketing Co. Also responsible for approbation of rework or special inspection operations conducted within the DC

Responsible for Quality Management of temperature-controlled facilities: responsible for ensuring compliance with monitoring of ambient environment (temperature and humidity as required) while maintaining oversight for the identification and communication of temperature excursions occurring within the DC to appropriate partner for the oversight for the investigation and subsequent remediation activities

Responsible for Quality management input on the Warehouse Management Systems and oversight of records and document management and provide input to the development of validation, implementation, and changes of Cal/PM, CAPA, NC, IA, Doc Mgmt software systems

Review and provide guidance to 3PLs on creation and revisions to their procedures to ensure alignment with Kenvue quality agreements, service contracts, and Kenvue procedures and policies

Responsible for the oversight, management and processing of complaints reported to DC (OS&D Product and Service-related complaints) including tracking and trending

Create, review, and approve assessment plans, risk assessment reports. Evaluate overall compliance risk, recommend corrective actions and monitor progress. Responsible for the execution of DC QSCAN risk evaluation. Makes quality decisions based upon assessments of compliance risks balanced with the overall business needs. Advance all appropriate issues to CQ Leadership

Responsible for conducting internal Quality audits of DCs (schedule, plan, conduct, and follow up). Responsible for oversight of DC facility licenses. Responsible for the co-management with 3PL of all Health Authority inspections (e.g. FDA) conducted at the DC, including reviewing the preparation plan with on-site management

Qualification

Quality Management SystemsFDA 21 CFR Part 820ISO 9001ISO 13485QA/QC experienceRegulatory inspectionsSix SigmaLeanWarehouse Management SystemsRoot cause analysisTemperature control TransportationCommunication skillsCollaboration skillsProblem solvingDecision-making