Manager Distribution Quality & Compliance

Manager Distribution Quality & Compliance

我們做什麼

在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

我們是誰

我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

Role reports to：

Sr Mgr Distrib and Supplier Quality CQ

位置：

North America, United States, Indiana, Mooresville

工作地點：

完全現場

你會做什麼

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

對您有什麼好處

$124,100.00 - $175,200.00

這考慮了許多因素，包括工作地點、候選人的技能、經驗、教育水準和其他與工作相關的因素

Kenvue 很自豪能成為一個機會均等的雇主。所有合格的申請人都將根據業績獲得就業考慮，不分種族、膚色、宗教、性別、性取向、性別認同、年齡、國籍或受保護的退伍軍人身份，並且不會因殘疾而受到歧視。