국가임상시험지원재단

Are you passionate about ensuring top-notch quality in the pharmaceutical industry? Do you have the expertise to lead a team and drive compliance with global standards? If so, we invite you to join our team as a (Sr.) Quality Assurance Manager at Novo Nordisk South Korea. Read more and apply today for a life-changing career. Novo Nordisk has been globally recognized as the Best Place to Work, topping the ranks for two consecutive years in 2022 and 2023. It is an exciting time to join Novo Nordisk and be part of a dynamic company in an even more dynamic industry, helping us achieve our aspirations to establish a global presence in the industry. [About the department] Novo Nordisk South Korea is a dynamic affiliate in a high growth phase, with a strong purpose to bring life-changing products to people living with Diabetes, Obesity and other serious chronic diseases. Recently certified in APAC as a Great Place to Work, we pride ourselves on continually striving for the best performance to meet our purpose, and to live the Novo Nordisk Way, which includes an absolute commitment to Business Ethics, Compliance and Quality. [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. The Senior job title will be decided based on the experience level and qualifications of the candidate. ?Quality Management System: As the local Qualified Person (Registered Pharmacist, Quality Responsible Person), the role will oversee Good Distribution Practice (GDP) compliance in alignment with market regulatory requirements. Responsibilities include conducting thorough impact assessments of GDP/Good Import Practice (GIP) and local regulations, ensuring their effective implementation within our operations. The role will also maintain and manage Quality System Documentation, encompassing procedures and records that uphold the quality standards. Additionally, implement robust management processes for deviations and corrective and preventive actions (CAPA), change control, self-inspection, complaint handling, and GDP training, as well as oversee the Annual Product Review (APR) and other key aspects of the general quality system management to ensure continuous improvement and compliance. ?Quality Operations: The Quality Operations role involves ensuring product quality through batch release or approval to the market, overseeing supplier management, including Quality Agreements, and approving local subcontracted activities that impact product quality. Key responsibilities include evaluating and confirming supplier qualification status, managing local QC testing, reviewing Certificates of Analysis (CoA), and overseeing local product release when applicable. The role also coordinates and approves analytical method transfers for product launches, manages compliance and quality events with the market team, and promptly performs market actions, such as recalls and mock recalls for medicinal products. Additional duties include supporting the Supply Chain and managing local redressing when required to maintain quality and compliance within the operation. ?Local Distribution Management: Overseeing warehouse management and managing transportation processes as well as supervising third-party laboratories. ?Inspections and Regulatory Surveillance: Maintaining the Import license with the Local Health Authority (LHA), supporting Global Quality Audits within the market, preparing for and leading Health Authority (HA) inspections at the local entity, and monitoring external regulatory requirements to ensure ongoing compliance. [Qualification] ?10-18 years of progressive experience within the quality function of the pharmaceutical industry or with regulatory agencies. Pharmacist certification is mandatory. ?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 Korean language fluency as well as English communication skills are required. [지원방법 및 링크] Kindly upload your CV to our online career page (click on Apply and follow the instructions). https://www.novonordisk.com/content/nncorp/global/en/careers/find-a-job/job-ad.317068.en_GB.html [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.