Market Quality Head (차,부장급)-00000B3O
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.
Job title: Market Quality Head / 차,부장급
To be responsible for the implementation of a Quality Management System (QMS) for all GXP related activities (pre- and post-marketing) at the LOC / Cluster level, to ensure that the implementation meets the requirements of J&J Quality Policy POL-001, applicable regulations and voluntary standards and to ensure the QMS is appropriately maintained.
1.1 MAIN ACTIVITIES/TASKS:
- Be responsible at LOC/Cluster level for the development and deployment of a QMS that is applicable to the activities of the local operating companies by:
- establishing and maintaining the local QMS.
- ensuring the appropriate local resource infrastructure is in place to deploy and maintain the QMS.
- ensuring that all process documents are prepared, reviewed, approved, implemented and updated appropriately.
- ensuring that all local processes are compliant and consistent with applicable J&J policies, global and sector standards and global and regional processes (as applicable).
- providing advocacy for quality and compliance with regulatory requirements throughout the local organisation.(the LOC Q Head may not be the expert in all GXP areas, needs to liaise and get appropriate input from relevant GXP functions)
- co-ordinating all quality related activities across the LOC / Cluster to ensure that the LOC / Cluster remains compliant as described above without adversely affecting the ongoing conduct of business.
- ensuring that all required training is provided and managed appropriately for all GxP functions.
- ensuring that appropriate processes and systems are in place across the LOC / Cluster for the management of change with potential impact on QMS.
- Ensuring any concerns regarding product quality, safety or compliance are escalated per STA-00002.
- identifying key performance indicators for, and then monitoring performance of the QMS per SOP-12052.
- Coordinating a programme of continuous improvement of the local QMS.
- Be responsible to the Management Board of the LOC / Cluster for the performance of the QMS and any need for improvement by:
- identifying, coordinating and presenting appropriate metrics, including progress against deliverables, and need for improvement at LOC/Cluster level.
- ensure mechanisms exist for monitoring regulatory requirements, together with other relevant functional area owners.
- Ensure escalation of problems with alignment of processes, and/or potential compliance risks with regard to meeting customer needs and regulatory/legal requirements
- Ensure the LOC / Cluster is properly represented on any global / regional quality projects driven by the senior regional Market Quality head.
A background of working in pharmaceutical/biotechnology industries with a substantial experience of either Quality Assurance or Process methodologies
Continuous development into current GxP regulations, guidelines and industry quality standards.
Excellent interpersonal and communication skills, self-motivated, clear thinker.
Relevant university degree or business qualifications in areas applying process methodologies.
Knowledge in RA / QC / QA / 공장 경험 근무자
Generally requires (8-10) years related experience
Experience in submission and approvals for new pharmaceutical products
Good communication skill in verbal & written
Primary Location: Asia Pacific-South Korea-Seoul-Yongsan-gu
Organization: Janssen Korea, Ltd. (7220)
Job Function: Quality (Generalist)
Johnson & Johnson Family of Companies - 16 months ago
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