Manager Distribution Quality & Compliance

Manager Distribution Quality & Compliance

Cosa facciamo

A Kenvue, ci rendiamo conto dello straordinario potere della cura quotidiana. Costruiti su oltre un secolo di tradizione e radicati nella scienza, siamo la casa di marchi iconici, tra cui NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® che già conosci e ami. La scienza è la nostra passione; la cura è il nostro talento.

Chi siamo

Il nostro team globale è composto da ~ 22.000 persone brillanti con una cultura del posto di lavoro in cui ogni voce conta e ogni contributo è apprezzato. Siamo appassionati di intuizioni, innovazione e impegno a fornire i migliori prodotti ai nostri clienti. Con competenza ed empatia, essere un Kenvuer significa avere il potere di avere un impatto su milioni di persone ogni giorno. Mettiamo le persone al primo posto, ci prendiamo cura di noi, ci guadagniamo la fiducia della scienza e risolviamo con coraggio - e abbiamo brillanti opportunità che ti aspettano! Unisciti a noi per plasmare il nostro futuro e il tuo. Per ulteriori informazioni, fare clic su here.

Role riporta a:

Sr Mgr Distrib and Supplier Quality CQ

Posizione:

North America, United States, Indiana, Mooresville

Luogo di lavoro:

Completamente in loco

Cosa farai

The Manager of Distribution Quality and Compliance provides oversight of the Quality Management Systems and its compliance to all applicable laws and regulations at the Distribution Center. Working closely with various internal and external partners you drive innovation within functional area while ensuring initiatives are delivered in a compliant and efficient manner.

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.

What we are looking for

Required Qualifications

• A Bachelor's degree is required, preferably in an Engineering, Life Sciences, or Technical field
• 6-8 years of proven experience in a highly regulated industry is required. QA/QC experience in the Medical Device, Pharmaceutical or Consumer products industry and experience with regulatory inspections is preferred.
• Strong knowledge of FDA 21 CFR Part 820 and/or ISO 9001 and/or ISO 13485 and/or ERP systems is required.
• Strong communication, collaboration, problem solving, decision-making, and root cause analysis skills are required.
• This position is located at our Distribution Center and may require up to 20% domestic travel

Desired Qualifications

• Six Sigma, Lean, 5S or ASQ Certification and trainings are preferred. Experience with Warehouse Management Systems is preferred.
• Experience with Temperature control Transportation is preferred.

#LI-SR1

Cosa c'è per te

$124,100.00 - $175,200.00

Questo tiene conto di una serie di fattori tra cui il luogo di lavoro, le competenze del candidato, l'esperienza, il livello di istruzione e altri fattori legati al lavoro.

Kenvue è orgogliosa di essere un datore di lavoro per le pari opportunità. Tutti i candidati qualificati saranno presi in considerazione per l'impiego in base al merito, indipendentemente da razza, colore, religione, sesso, orientamento sessuale, identità di genere, età, origine nazionale o stato di veterano protetto e non saranno discriminati sulla base della disabilità.