Commercial Quality Lead, South Korea

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：

位置：

工作地點：

你會做什麼

Commercial Quality Lead

This position reports to Head of Q&C metropolitan Asia & Japan and is based at Seoul, Korea.

Who we are

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® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the life of 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: Head of Q&C Metropolitan Asia & Japan

Location: Seoul, Korea

Travel %: 10~20%

What you will do 

The [Commercial Quality Lead] is responsible for:

Key Responsibilities

1.        Manages/oversees product compliance to internal and MFDS requirements prior to product release for OTC, Quasi‐Drug, and Cosmetics (general and functional)

2.       Leads and manages import testing at in-house & local external laboratory for OTC, Quasi‐Drugs and Cosmetics to meet local requirements.

3.       Manages Escalations, resolutions and effective CAPAs, and effectively participate in the Escalation meeting, Quality Review Board (QRB) to decide appropriate action and its reporting to Health Authority.

4.       Be the primary quality partner for Korea business / commercial and deliver organization, 3PL and other cross-functional teams to ensure compliance of all commercialized products with local regulations at all times.

5.       Ensures consistent and updated Quality Responsibility Agreement with distributor, external lab, and third party logistics

6.       Contributes Quality intelligence program to assess and monitor Korean regulation, standards and guidance document related to GxP, as well as Kenvue standard.

7.       Collaborates with cross‐country/functional business partners in timely and compliant execution of new product introductions (NPI)/development (NPD) and promotions

8.       Drives the implementation of relevant Enterprise Quality Policy Standards and Consumer sector global/regional standards and procedures.  Leads and manage local SOPs establishment and maintains those compliance statuses.

9.       Drives continuous improvements to Quality Management System and manage End-to-End Franchise product quality.  Follows through GRC and other management commitments.

10.     Ensures robust execution of quality issue management process (nonconformance and CAPA) and change control for imported product and domestically manufactured Cosmetics.

11.      Ensures robust execution of complaint management process including complaint evaluation, closure, and trending with relevant Make/Source/and cross‐functional members. Approves complaint investigation report for Korea Sales & Marketing (S&M) group.  Support an appropriate and timely closure of related to quality and compliance customer complaint at 3PL/Supplier.

12.     Reviews and approves product‐related documents, such as COA/COC, copy and graphics specifications, finished put‐up specifications, re‐pack/re‐label batch records, transportation protocols, packaging component specifications, Approval for Product Release (APR), First Article Inspection (FAI), etc.

13.     Manages MFDS inspections and internal audits in Korea regarding imported products and DC related. Supports Audit Action Plan (AAP) management. Manages self‐inspection and reports to Yongin‐city Health Center

14.     Ensures Distribution Center (DC) meets all appropriate related requirement such as MFDS and Kenvue requirements (e.g receiving, pick, pack, shipping, storage condition and distribution)

15.     Maintain for quality management of repacking, relabeling, over labeling and reworking operations conducted by repacker

16.     Ensure robust execution of in-house laboratory compliant with local & Kenvue requirement.

What we are looking for

Required Qualifications

• Bachelors or Masters degree in Science, preferably in Pharmaceutical Sciences, Chemistry or Pharmacy.

Desired Qualifications

• Over 10 years of related QA/QC or manufacturing experiences
• Good command of English for effective oral/written communication.
• Knowledge of MFDS regulation, cGMPs, Quality Systems and product quality attributes.
• QA/QC compliance experience is preferred
• Good insight of Good Laboratory Practice
• Good communication capability to facilitate effective interaction and motivate the team members.
• Self leadership and motivation with high personal integrity and application of Kenvue value.
• Make sure to indicate if any specialized software or other technical skills are required to perform job responsibilities

What’s in it for you

• Competitive Total Rewards Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Employee Resource Groups 
• This list could vary based on location/region

*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

如果您是殘障人士，請查看我們的 殘障人士援助頁面瞭解如何申請便利