At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Quality
Job Sub Function:
Customer/Commercial Quality
Job Category:
People Leader
All Job Posting Locations:
Seoul, Korea, Republic of
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Essential Job Duties and Responsibilities
- As CQ Compliance lead for LOC, be responsible for the implementation of a Quality Management System (QMS) for end-to-end GxP related activities (pre-and post-marketing, including Controlled Substance) at the LOC level
- Responsible for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GxP activities the LOC and Deliver Operations undertake including but not limited to GMP/GDP activities, unless agreed to be otherwise managed by other Q&C functions such as GCDO, MAF, Supply Chain Quality, and other sector CQ. In this role he/she has defined authority and responsibility for ensuring that quality system and processes are implemented and maintained according to Commercial Quality Manual.
Minimum Qualification
Quality System
- Implement the Quality System via transposition of the requirements of the Commercial Quality Manual.
- Maintain an up-to-date list of all relevant product sourcing, supply routes (including exports), product licenses (marketing authorizations), relevant authorizations (e.g. manufacturing, packaging, importation, warehousing, distribution, testing, narcotics handling, etc.), and TA.
- Responsible for updating and approval of procedures in accordance with local GxP regulations, CQ Manual and J&J requirements.
- Execute minimum requirements regarding lifecycle management of GxP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity.
- Ensure the provision of appropriate training for all job functions with GxP responsibilities.
- Ensure appropriate internal and external change control systems are in place and are followed.
- Manage the preparation, execution and follow up for external inspections, and report these and any other relevant field action activity into the relevant system.
- Monitor quality system performance versus local GxP regulations, CQ Manual and J&J requirements via use of pertinent business and compliance metrics and goals.
- Drive continuous improvement in the Quality System using quality system performance information, in conjunction via periodic internal audits, deviation management, CAPA management and performance reviews.
- Notify and engage management and affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures
Quality Process
- Ensure that all Marketing Authorizations / Product Licenses, Manufacturing / Packaging and / Import / Distribution Licenses are available and kept up to date for all marketed products.
- Conduct regular (self-)inspections of GxP practices with focus on GMP/GDP activities, that are applicable on the supply chain within the responsibilities of the Local Operating Company.
- Oversight and support on all oversea Health Authority inspections
- Provide an effective procedure and adequate resources to handle product and AE complaints, escalate critical product issues and conduct recalls and other field actions in a timely manner (including outside business hours).
- Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, PQV, Supply Chain Quality, Deliver Operations, JJRC, and any other functions supporting complaint management.
- Collaborate with CQ operation team in new product introduction and all other product portfolio lifecycle management processes
- Act as back-up Qualified Person for local products release in Korea market.
Controlled substance
- Ensure the compliance of controlled substance related processes end-to-end for Korea, including JSC, Deliver, R&D and LOC.
Lead & develop corresponding team
- Lead Quality Compliance team through regular conversations and coaching to identify development need/opportunities and to provide proper support.
- Establish training matrix and ensure necessary training is provided for team
Other requirements
Experience, Skills and Knowledge:
- Registered Pharmacist in Korea required
- Minimum of 5 (ideally 10) years’ of experience in Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations, Distribution Warehouse management, Regulatory Affairs and knowledge of business operations.
- Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes;
- Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners;
- Strong knowledge of cGMPs and other Quality Systems
- Strong knowledge of Korean local regulations
- Knowledge of the Quality Management System as per ISO9001 & 13485 and GxP
- Full competency in conversation and writing in local languages and English
Competencies:
- Strong external and internal collaboration
- Engage in transparent and constructive conversations.
#LI-Hybrid
Legal Entity
Innovative Medicine
Job Type
Regular
Application Documents
Free-form resume AND cover letter is required (in Korean or English).
Application Deadline
Open until the position is filled.
Notes
- Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities upon submission of relevant documents as per applicable laws.
- Only candidates who pass the resume screening will be notified individually. However, notifications may be delayed due to company circumstances.
- If any false information is found in the application documents, the hiring may be canceled even after the offer is confirmed, and future applications may be restricted.
- Submitted documents will not be returned and will be deleted upon request.
Required Skills:
Preferred Skills:
Compliance Management, Continuous Improvement, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Inclusive Leadership, ISO 9001, Leadership, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Processes, Quality Standards, Standard Operating Procedure (SOP), Team Management
