[존슨앤드존슨] Business Quality Manager

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.


1. 포지션: Business Quality Manager
2. 계열사: 존슨앤드존슨 컨슈머 (Consumer)
3. 근무지: 서울시 용산구


[Summary]
Oversight of Quality & Compliance and Quality Systems execution in compliance with local regulatory requirements and J&J policies and standards. Accountable for all local activities necessary for product introduction and authorization for product release as a registered Marketing Authorization Holder.


[Responsibilities]
1) Manages/oversees product compliance to internal and MFDS requirements prior to product release for Quasi-Drug, and Cosmetics (general and functional)
2) Oversee/support local external laboratory selection and arrangement of Consumer Quasi-Drug and Cosmetic release testing.
3) Manage field actions and escalations
4) Partners with Customer Logistics Service (CLS) Q&C to ensure compliance of Distribution Center (DC)
5) Ensures consistent and updated Quality Responsibility Agreement with Janssen QC lab, external lab, and third party logistics
6) Proactively reviews and monitors relevant global and domestic regulations for changes to ensure maintaining compliance
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
9) Establishes and maintains local SOPs and monitors for compliance
10) Drives continuous improvements to Quality Management System. Follows through JJRC and other management commitments.
11) Ensures robust execution of quality issue management process (nonconformance and CAPA) and change control for imported product and KGSP for Janssen OTC products
12) Ensures robust execution of complaint management process including complaint evaluation, closure, and trending with relevant Make/Source/CLS Quality and cross-functional members. Approves complaint investigation report for Korea Sales & Marketing (S&M) group
13) 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.
14) Prepares, facilitates, and manages LOC for audits.
15) 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
16) Partners with Source/CLS Quality to effectively manage suppliers are and distributors (non-make) 


[Requirements]
Education/License: Bachelor's degree or equivalent in Life Sciences; pharmacist license holder (Required)

Experience: Typically 5 years of related QA/QC or manufacturing experience with at least 2 years of direct experience in managing staff or as lead project management role.

Competencies/Skills:
1) Good command of English for effective oral/written communication.
2) Knowledge of MFDS regulation, cGMPs, Quality Systems and product quality attributes. QA/QC compliance experience is preferred
3) Demonstrated experience in investigations, change control, validation, batch record review, analytical data review and/or audits
4) Strong leadership/interpersonal skills for influencing and collaboration in a team matrix environment
5) Strong Decision Making / Problem Solving skills
6) Ability to prioritize and meet deadlines while handling multiple projects under time pressure
7) Practical project management software and spreadsheet skills, proficient computer operation skills.
8) Good organizational skills, detail-oriented & accurate, analytical skills.
9) Local market acumen a plus
Travel: Domestic (~20%) and APAC travels (~5%)


[JD 확인 및 지원 방법] PC & mobile 지원 모두 가능
www.careers.jnj.com -> Requisition number 1700178806W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”


[제출 서류]
영문 자유 양식의 이력서/자기소개서


[서류 마감일] 
채용시 마감


[유의사항] 
- 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비 하시기 바랍니다.
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- 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다. www.careers.jnj.com


[이메일 문의]
recruitment-jnj@ITS.JNJ.COM