Quality Assurance Manager - Seoul - Novo Nordisk와 관련된 현재 작업
-
Compliance Assurance Partner
6 개월전에
Seoul, 대한민국 AstraZeneca 풀타임The Compliance Assurance Partner (AP) is primary accountable for delivery an Assurance activity and conduct investigation for your responsible market and support GCI in Global Investigations providing the local market business expertise. As an AP, you are required to shirting the mind set of traditional focus from monitoring to provision of proactive...
-
Quality Specialist
3 개월전에
Seoul, 대한민국 Thermo Fisher Scientific 풀타임: Develop and maintain Quality Management System in South Korea by promoting Quality Mindset within the organization. Maintain the Quality Management System in compliance with regulatory (including Korea Medical Device Act) and internal requirements. Ensure compliance with current regulations and standards and obtaining and maintenance of ISO 13485...
-
Principal Quality Engineer
6 개월전에
Seoul, 대한민국 Skyworks 풀타임If you are looking for a challenging and exciting career in the world of technology, then look no further. Skyworks is an innovator of high performance analog semiconductors whose solutions are powering the wireless networking revolution. At Skyworks, you will find a fast-paced environment with a strong focus on global collaboration, minimal layers of...
-
Principal Quality Engineer
6 개월전에
Seoul, 대한민국 Skyworks 풀타임If you are looking for a challenging and exciting career in the world of technology, then look no further. Skyworks is an innovator of high performance analog semiconductors whose solutions are powering the wireless networking revolution. At Skyworks, you will find a fast-paced environment with a strong focus on global collaboration, minimal layers of...
-
Solutions Architect
2 개월전에
Seoul, 대한민국 verticurl 풀타임Responsibilities: Project Management: Lead onshore/offshore project teams and manage project timelines, ensuring the successful delivery of projects within scope, on time, and on budget. Account Management: Manage client relationships, ensuring their needs are met and expectations exceeded. Collaborate with internal teams to deliver...
-
Quality Inspector
3 개월전에
Seoul, 대한민국 Vestas 풀타임Region APC > Customer Project Execution - APAC > Operational Quality In Execution Quality, Integration & Standards we are excited to have an incredible collaborative work environment of highly skilled supervisors, ready to support our projects and ad hoc assignments in Asia Pacific Region. Our supervisors work on activities in quality on-/offshore,...
-
Seoul, 대한민국 Vestas 풀타임Vestas Technology & Operations > Quality > Sales Quality We develop the wind energy products and technologies that substantially facilitate the global renewable energy transition and bring the highest possible value to our customers and to Vestas. Sales Quality is a department within Vestas Quality, that has the purpose of delivering quality...
-
Sr QA Specialist, APAC
6 개월전에
Seoul, 대한민국 Boston Scientific 풀타임Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the...
-
Seoul, 대한민국 Microsoft 풀타임Overview Microsoft is on a mission to empower every person and every organization on the planet to achieve more. Our culture is centered on embracing a growth mindset, a theme of inspiring excellence, and encouraging teams and leaders to bring their best each day. In doing so, we create life-changing innovations that impact billions of lives around the...
-
Senior Specialist, Quality
6 개월전에
Seoul, 대한민국 Cardinal Health 풀타임The Company and Business Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company, providing customized solutions for hospitals, health systems, pharmacies, ambulatory surgery centers, clinical laboratories, and physician offices worldwide. The company provides clinically proven...
-
QA Specialist
6 개월전에
Seoul, 대한민국 Haleon 풀타임Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep...
-
Brand Change Specialist
6 개월전에
Seoul, 대한민국 Diageo 풀타임Description : Job Title : Brand Change Specialist Location : Korea, S eoul Contract Term : Permanent Function : Supply Reports to : Technical Manager About us From Arthur Guinness to Johnnie Walker, our business was founded on people of great character, and in 250 years, nothing’s changed. We’re the world’s leading premium...
-
Quality Trainer
3 개월전에
Seoul, 대한민국 Dyson 풀타임About the Role The primary focus of the trainer is to develop and deliver the training for the required skillsets – improving the service capability and operational effectiveness. They will be required to engage with internal sales, marketing and group/region customer service to develop training materials and tools. Also, they’re responsible for...
-
QA Manager
4 개월전에
Seoul, 대한민국 Stryker Korea Ltd. 풀타임Work Flexibility: Hybrid Critical success factors / key deliverables: Make company be compliant w/ MFDS requirements in terms of post market surveillance including labeling, Importer’s duty by MDA, maintenance of QMS, ensuring the appropriate product release to customer, etc Do and manage QA team to perform post market surveillance activities like...
-
Lab Compliance QA
6 개월전에
Seoul, 대한민국 622 GlaxoSmithKline Korea Limited 풀타임This position is responsible for providing Quality Assurance in enabling the GSK Quality requirements including all applicable local regulations, but not limited, are embedded and complied in its own working operations and executing areas. Ensuring product supply to the market are safe, regulatory compliance and timely manner. Providing the...
-
Seoul, 대한민국 Montblanc 풀타임KEY RESPONSIBILITIES Key responsibility 1: Management of Client Service Operations - Manage customer care service across all Montblanc networks; Domestic retail, Travel retail and Wholesale dealer POS - Actively participate in CS process updates and improvements for better client experiences in boutiques - Identify training & coaching needs...
-
Procurement Manager in Korea
6 개월전에
Seoul, 대한민국 Haleon 풀타임Align with appropriate Hub and Global category teams and work in collaboration with these teams to provide local business requirements and market information to support effective collaborative regional and global strategy creation and execution. Execute global sourcing strategies for multiple spend categories in scope of responsibility, operating with a...
-
Seoul, 대한민국 Cummins Inc. 풀타임DESCRIPTION Key Responsibilities: Works within defined human resource processes ( compensation, benefits, performance management, exit interviews, relocation, and immigration support) and may help determine the appropriate actions required in more complex situations. Provides general information and guidance on benefits and compensation. Ensures...
-
Manager(FMCG CS)
2 개월전에
Seoul, 대한민국 NielsenIQ 풀타임Job Description ABOUT THIS JOB This position will be responsible for maintaining/enhancing customer relationships with an aim to improve client satisfaction, via increasing client ROI & driving the adoption of new capabilities. This role will lead a delivery team to ensure prompt delivery of service, ensure the quality of the data insight with...
-
CRA Line Manager
6 개월전에
Seoul, 대한민국 IQVIA 풀타임Job Overview Manage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives. Essential Functions • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and...
Quality Assurance Manager
2 개월전에
Are you passionate about ensuring the highest quality standards? Do you have experience in quality assurance and GDP for pharmaceutical products? If so, we have an exciting opportunity for you as a Quality Assurance (QA) Manager in our Seoul office. Read more and apply today for a life-changing career.
The position
In this role, you will undertake all necessary initiatives to ensure that Quality within South Korea is aligned to Novo Nordisk’s global procedures, processes and strategies as well as people management. This position is the head of the QA team and has four direct reports. The QA team is a part of the Legal, Compliance, and Quality department, and it reports directly to both the local Legal, Compliance and Quality Director and regional Quality Director.
Quality Management System:
- Act as the local Qualified Person (Registered Pharmacist, Quality Responsible Person) responsible for GDP in accordance with market regulatory requirements.
- Conduct GDP/GIP and local regulations impact assessments and implementation.
- Maintain Quality System Documentation, including procedures and records.
- Implement Deviation & CAPA management, Change control management, Self-inspection, complaint management, GDP training management, APR, and other general quality system management.
Quality Operations:
- Ensure product quality through batch release or approval to the market.
- Oversee supplier management, including Quality Agreements and approving local subcontracted activities impacting product quality.
- Evaluate and confirm supplier qualification status.
- Manage local QC testing, CoA review, and local product release when applicable.
- Coordinate and approve analytical method transfers to meet product launches when applicable.
- Handle compliance/quality events with the impacted market team.
- Coordinate and promptly perform market actions, including recalls and mock recalls for medicinal products.
- Support the Supply Chain and manage local redressing if required.
Local Distribution Management:
- Oversee warehouse management.
- Manage transportation processes.
- Supervise third-party laboratories.
Inspections and Regulatory Surveillance:
- Maintain the Import license with the LHA.
- Support Global Quality Audits in the market.
- Prepare for and lead HA inspections in the local entity.
- Monitor external requirements.
Qualification
- Pharmacist certification is mandatory
- 10-15 years of progressive experience within the quality function of the pharmaceutical industry or with regulatory agencies
- Minimum 2-3 years of people management experience
- Knowledge and experience in pharmaceutical operations, quality control, distribution and international regulations are essential and Global MNC / Matrix Organization experience is a plus
- Good knowledge of QA processes, SOPs, and Compliance guidelines, including proficiency in GDPs and the requirements for pharmaceutical products distribution
- Strong interpersonal and communication skills with supportive, persuasive, passionate and energetic mindset
- English fluency is preferred
Contact
Kindly upload your CV to our online career page (click on Apply and follow the instructions).
Deadline
Until the completion of recruitment. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
#LI-AMS1
