Seoul, South Korea · Hybrid
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 in…
Skills: Audit Management, Business Savvy, Coaching, Communication, Compliance Management
Warsaw, Masovian Voivodeship, Poland · On-site
$156k–$248k/yr
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 in…
Skills: Business Development, Compliance Management, Customer Centricity, Customer Training, Data Savvy
Spring House, Pennsylvania, United States · On-site
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 in…
Skills: Cell Culture, Downstream Processing, R, Matlab, Python
Vienna, Austria · Hybrid
$69k–$109k/yr
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 in…
Skills: Analytical Reasoning, Business Data Analysis, Coaching, Communication, Competitive Landscape Analysis
Irving, Texas, United States · On-site
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 in…
Skills: Administrative Support, Agile Manufacturing, Assembly Operations, Detail-Oriented, Execution Focus
Puebla, Coahuila, Mexico · On-site
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 in…
Skills: Regulatory Affairs, Quality Assurance, CAPA Management, Team Leadership, Controlled Substances Management
Mobile, Alabama, United States · On-site
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 in…
Skills: Clinical Support, Orthopedic Surgical Knowledge, Case Coverage, Asset Management, Hospital Billing
Palm Beach Gardens, Florida, United States · Hybrid
$122k–$213k/yr
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 in…
Skills: Brand Marketing, Brand Positioning Strategy, Business Alignment, Business Storytelling, Business Valuations
Rio de Janeiro, Rio de Janeiro, Brazil · On-site
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 in…
Skills: Medical Affairs, Stakeholder Engagement, Medical Communications, Clinical Experience, Competitive Landscape Analysis
Ciudad Juarez, Chihuahua, Mexico · On-site
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 in…
Skills: Analytical Reasoning, Coaching, Computerized Equipment Skills, Developing Others, Emerging Technologies
Bogota, RAP (Especial) Central, Colombia · Hybrid
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 in…
Skills: Process Improvement, Lean Six Sigma, Data Analysis, Process Automation, Project Management
Calgary, Alberta, Canada · On-site
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 in…
Skills: Business Behavior, Customer Centricity, Execution Focus, Goal Attainment, Innovation
Jacksonville, Florida, United States · Hybrid
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 in…
Skills: Analytical Reasoning, Business Behavior, Coaching, Collaborative Selling, Communication
Añasco, Puerto Rico, United States · On-site
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 in…
Skills: Manufacturing Engineering, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Project Management, Problem Solving
Mayagüez, Puerto Rico · On-site
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 in…
Skills: Clinical Sales, Demand Generation, Product Management, Market Analysis, Technical Support
Hyderabad, Andhra Pradesh, India · Hybrid
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 in…
Skills: Advanced Analytics, Analytical Reasoning, Communication, Data Analysis, Database Management
Los Angeles, California, United States · On-site
$117k–$201k/yr
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 in…
Skills: Analytics Dashboards, Clinical Experience, Clinical Research And Regulations, Competitive Landscape Analysis, Critical Thinking
Beerse, Flanders, Belgium · Hybrid
$73k–$115k/yr
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 in…
Skills: Chemical Plant Operations, New Product Introduction, Process Models, Process Scale Up, Process Engineering
Fuji, Japan · On-site
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 in…
Skills: Analytical Testing, GMP/GCTP Compliance, Data Integrity, Method Validation, Laboratory Equipment Management
Horsham, Pennsylvania, United States · On-site
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 in…
Skills: Brand Marketing, Brand Positioning Strategy, Business Alignment, Business Storytelling, Business Valuations
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Lead and oversee Handling Storage and Distribution (HSD) quality activities for the Korea market to ensure regulatory compliance. Partner with Supply Chain and Regulatory Affairs to manage product distribution, labeling, and post-market surveillance.
Requires a Bachelor's degree in Quality, Engineering, Life Sciences, or a related field with 4-6 years of experience in quality or regulatory roles. Proficiency in Korean is required, with a strong understanding of quality systems and regulatory expectations for commercial operations.
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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Customer/Commercial QualityDePuy Synthes is recruiting for a HSD/QA Lead Korea
Job Overview
The a HSD/QA Lead – Korea is responsible for Handling Storage and Distribution (HSD)–related quality activities within Commercial Quality for the Korea market. This role ensures compliant execution of distribution, storage, handling, and post‑market processes in alignment with regulatory requirements and internal quality standards. The position plays a critical role in safeguarding patient safety, ensuring regulatory readiness, and supporting reliable product supply by partnering closely with Commercial, Regulatory Affairs, Supply Chain, and Global Quality teams.
Key Responsibilities
Lead and oversee HSD‑related Commercial Quality activities for the Korea market, ensuring compliance with applicable regulations and quality system requirements.
Serve as the primary Commercial Quality contact for HSD and local QA-related activities in Korea.
Provide quality oversight for distribution, storage, handling, and logistics activities across the local network, including product disposition, shipment holds, and distribution-related quality decisions
Partner with Supply Chain, Commercial, and Regulatory Affairs teams to ensure compliant product distribution and lifecycle management, and product license renewal activities, providing quality leadership and timely delivery of quality-related documentation and post-market evidence required for regulatory submissions.
Lead quality review and approval of local labeling, eIFU, and product information changes in collaboration with Regulatory Affairs.
Lead and ensure compliance with UDI management, supply record reporting, and product traceability requirements, where applicable.
Support Lead and oversee post‑market surveillance activities, including complaint handling ,field action , recalls and trend analysis coordination as required.
Monitor HSD‑related quality risks, trends, and performance metrics; drive corrective and preventive actions.
Support Lead and coordinate internal audits, external audits, 3rd party audit and health authority inspections related to HSD and Commercial Quality processes.
Drive continuous improvement initiatives to strengthen compliance, consistency, and operational effectiveness.
Qualifications
Education:
Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, Supply Chain, or a related discipline (required).
Advanced degree in a scientific, quality, or regulatory field (preferred).
Experience and Skills:
Required:
Typically 4-6 years of progressive experience in Quality, Regulatory, Compliance, roles within a regulated industry.
Demonstrated experience supporting distribution, logistics, or post‑market quality activities.
Strong understanding of quality system requirements and regulatory expectations for commercial operations.
Experience supporting audits, inspections, or regulatory assessments.
Ability to analyze quality risks and translate requirements into practical actions.
Preferred:
Experience in medical devices, healthcare, or other highly regulated industries.
Familiarity with Korean regulatory and distribution quality requirements.
Experience working in a multinational or matrixed organization.
Prior experience leading or coordinating HSD or Commercial Quality activities.
Quality or Regulatory certifications (e.g., ASQ, RAC).
Strong stakeholder management, communication, and problem‑solving skills.
Other:
Language: Korean required; English proficiency preferred.
Travel: Limited; occasional domestic travel within South Korea.
Certifications: Quality or Regulatory certifications preferred but not required.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. https://bit.ly/3reuMvK
At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. https://bit.ly/3reuMvK
