Quality Assurance Manager

Job Description

As the Responsible Person for South Korea, you are in charge of the QA import process and responsible for ensuring compliance with the technical and regulatory requirements related to the quality of finished products. Additionally, you are responsible for approving the release of such products for sale in South Korea.

You also serve as the Deputy Responsible Person for Taiwan.

• Responsibility for Release process for South Korea
  • Review RP/QP release documentation, shipping conditions and expiry date are in compliance with the regulatory national requirements and, consequently, perform local release of every import, where required.
  • Responsible Person signing off on release documentation for South Korea.
• Oversees Local Quality Management System consistent with in-country requirements and Biogen QMS
  • Oversees the documentation management system for local GDP procedures
  • Leads and coordinates Quality Management Reviews for South Korea Affiliate and Logistics Partner
  • Leads implementation and alignment of Global Quality Management Systems (Global Directives)
  • Oversees affiliate’s training program as Functional Learning Liaison
  • Responsible for the local management of Deviations, CAPAs, Change Control as initiator, investigator or QA
  • Responsible for the affiliates Quality Risk Management System as identifying potential risk, assessment and its escalation.
• Responsible for the maintenance of distribution applicable licenses for South Korea
  • Ensures that affiliate’s personnel and processes meet applicable requirements and maintains licenses and certificates
  • Ensures that Biogen products are handled in accordance with applicable licenses and requirements
  • Is up-to-date with cGDP, GIP and applicable regulatory requirements
  • Ensures that suppliers are approved in coordination with responsible departments. Reviews customer entitlement on an annual basis. Approves any subcontracted activities which may impact on GDP
  • Responsible for the disposition of product returns, rejected and potentially falsified medicinal products
  • Oversees distribution related complaints and deviations
  • Is the point of reference to management and employees for all matters relating to GDP, GIP and QA oversight of product distribution
  • Responsible for management of in-country quality sample
• GDP/GMP-related Audits and Inspections:
  • Accountable for GDP inspections with preparation readiness, coordination, hosting and required follow-up and CAPA implementation
    • Supports health authority Inspections with preparation readiness and coordination.
  • Hosts Affiliate Audits and coordinates related follow up and CAPA implementation
  • Leads and coordinates self-inspection program
  • Provides oversight of vendor management (affiliate external partners who perform GxP activities) including quality agreement maintenance
• Product related issues:
  • Participates in Distributed Material Review Boards and Recall Committees related product distributed in South Korea as Responsible Person.
  • Responsible for the coordination of local Product Recalls and mock recall exercises. Co-responsible for recall reconciliation and effectiveness checks
  • Oversees handling of Technical Product Complaint processes, supports related investigations and follow up as necessary
  • Ensures that suspected falsified product is immediately notified for investigation and coordinates local management as per Biogen procedures, assures that suspected falsified product under Biogen control is put on hold
  • Accountable for all communication with the Competent Authorities relating to product quality and ensure that the review of this communication is appropriate and approved
  • Oversees temperature excursion assessments
• Safety：Act as the backup Safety Designated Staff member
• Taiwan support: Part of a team supporting Quality Assurance activities to ensure maintenance of Biogen’s QMS in Taiwan & act as Deputy Responsible Person for Taiwan
• Global Commercial Quality support: As part of the Global Commercial Quality team, supports Global Commercial Quality with duties assigned from time to time

Qualifications

• Degree in Pharmacy (or equivalent) required.
• Must hold a Korea Pharmacist License.
• Experience PR in south Korea from biotech or pharmaceutical industry
• Proven knowledge of regulations in south Korea (Korean Pharmaceutical Affairs Act)
• Knowledge of and experience with the current Good Distribution Practice and importing processes.
• Experience with development and maintenance of quality management systems
• Proficiency in both oral and written English is required.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.