Johnson & Johnson Careers
[Consumer] Business Quality Manager
Requisition ID: 1805697980W
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.
Position: Business Quality Manager (Pharmacist)
Location: Yongsan-gu, Seoul
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.
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)
- Bachelor's degree above. Pharmacist license holder (MUST)
- More than 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
- 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
- Strong interpersonal skills for influencing and collaboration
- Strong Decision Making / Problem Solving skills.
- Local market acumen
[JD 확인 및 지원 방법]
www.careers.jnj.com -> Requisition number 1805697980W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”
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ohnson & Johnson Korea Sales & Distribution LLC (7227)