Quality Assurance Manager
10시간전에
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.
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