Manager Distribution Quality & Compliance

Kenvue•Mooresville, IN

3d•Onsite

About The Position

Kenvue is currently recruiting for a: Manager Distribution Quality & Compliance What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Who We Are Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here. Role reports to: Sr Mgr Distrib and Supplier Quality CQ Location: North America, United States, Indiana, Mooresville Work Location: Fully Onsite What you will do 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.

Requirements

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

Nice To Haves

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.

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.