Quality Assurance Manager, Seqirus Korea

A. Job Summary

The purpose of the Quality Assurance Manager role is to operate a local Quality system in the territory of responsibility in full compliance with all local requirements and company policies and to represent Seqirus Quality within a specific country/region.

• The Quality Assurance Manager serves as the primary point of communication to/from Global Quality, ensuring a timely and two-way communication platform is established.
• The Quality Assurance Manager ensures that quality activities remain compliant with local requirements and company policies; implements and maintains an appropriate local Q-system.
• The Quality Assurance Manager will act as Import Manager in line with Good Distribution Practices (GDP) and Pharmaceutical Act.
• The Quality Assurance Manager liaises with the Local Safety Officer (LSO) / Regional Safety Officers (RSO) and Local / Regional Regulatory Manager as required.
• The Quality Assurance Manager collaborates with affiliates, regional and global quality groups to foster a proactive approach of Quality.

B. Principal Accountabilities

1. Development and maintenance of quality operations which include (but is not limited to):

- Quality responsibility for all Seqirus products licensed, marketed or supplied within Territory of responsibility.

- Compliance with local as well as international regulations (e.g. GDP) and inspection readiness.

- Obtain / oversee the legal documentation required for pharma license into the Territory.

- Maintains up-to-date Quality Agreements.

- Develops, implements and maintains local Quality procedural documentation (in accordance with Global policies and procedures and the local document management system, if required).

- Monitors performance indicators (KPIs) related to quality compliance and owns Local Management Review for affiliate.

- Resolves quality-related issues.

- Archives and maintains all quality documents in line with Seqirus procedures and legal requirements.

2. Implementation, maintenance and execution of Quality Management Systems in compliance with local regulations and Seqirus standards, including but not limited to:

• Deviation Management
• Corrective Action Preventative Action (CAPA) Management
• Technical Product Complaints Management and reconciliation
• Change Control Management
• Documentation Management
• Training Management
• Recall Management
• Quality Management Review
• Self-Inspection Management
• Quality policy
• Quality Risk Management
• Recommendation for improvements to the quality system supporting Seqirus business in the country
• Product destruction

3. Quality Control Testing and Batch Release

- Oversight of National Assays / local QC testing in accordance to MFDS requirements

- Submission of Lot Release Protocols to MFDS per batch imported

- Make final batch disposition decision in SAP

4. Deviations and Corrective and Preventive Actions (CAPA) Management

- Ensures deviations are timely reported, investigated, managed and closed in relevant system according to Seqirus procedures.

- Oversees the affiliate / region CAPA process and ensures CAPA are implemented, followed-up and closed in a timely manner in relevant system.

5. Product Complaints Management

- Ensures relevant Product Complaints are timely reported, investigated, managed and closed.

- Supplied customer response letters to complaint reporters

- Performs Monthly reconciliation of complaints for South Korea

6. Change Control Management

- Ensures that an effective local change control process is implemented and compliantly managed within the affiliate.

- Oversees the affiliate Change Control process and ensures change requests are implemented, followed-up and closed in a timely manner.

7. Training Management

- Ensures systems for initial and continuous training plans are implemented and maintained for all personnel concerned, according to training plans and regulations.

- Ensures GDP Training is provided to the relevant personnel and ensures the relevant affiliate personnel is aware of the QA responsibilities (eg. product identification, suspected falsified medicines, Complaints, deviations etc).

- Oversees Seqirus Learning Management System.

8. Self-inspections & Quality Audits Management

- Ensures that self-inspections of the affiliate / regional operations and quality system are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.

- Supports and participates in corporate organization audits and assists in audit preparation activities, including the development of CAPA plans and the close out of any audit action items.

9. Risk Management

- Performs activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks identified.

- Manages the review and implementation of Quality Improvement/remediation plans for the Affiliate to ensure compliance and inspection readiness.

10. Quality Queries Management

- Manages in market temperature excursions queries received from customers and provides assessment of suitability

- Product Recalls & Field actions Management

• Acts as Recall Coordinator and promptly performs any recall operations for medicinal products from the market according to global quality procedures.
• Co-operates with marketing authorisation holders and national competent authorities in the event of recalls.
• Provides assistance as required in the event of a field action, as determined by the Recall Team.

11. Product Returns Management

- Ensures product returns are managed efficiently.

- Decides on the final disposition of returned products.

- Approves any returns to saleable stock where acceptable according to company and local regulatory policy.

12. Importation and Supply of Products/Unlicensed Products

- Ensures that any additional requirements imposed on certain products by national / regional law are adhered to e.g. specials, unlicensed imports.

- Support local Logistics and SAP when Seqirus' products are imported and released to local customers

13. Regulatory reporting and Quality Intelligence

- Acts as primary contact point to report any non-conformance delivered to the Affiliate as not meeting the requested quality criteria.

- Ensures local regulatory information related to quality topics and assess impact for Seqirus activities.

- Performs gap analysis for local regulatory updates and implements in local QMS

14. Local Health Authority Inspections

- Maintains affiliate inspection readiness at all times

- Prepares for and hosts the Health Authority where applicable for routine inspection

- Support Seqirus overseas manufacturing sites with MFDS inspections

C. Project Work

N/A

D. Scope/Accountability

- Marketing Authorisation Holder responsibilities for Seqirus South Korea affiliate

- Implementation and maintenance of the Local Quality Management System.

- Importation, testing oversight and release of commercial products to market.

- Local budgetary responsibilities.

E. Impact/Influence/Liaison

- Direct impact on the business through MAH responsibilities in the affiliate.

- Role will need to influence key stake holders from other functions within the affiliate and drive Quality culture through training and education.

- Will liaise with supply chain, logistics and global personnel for shipments and supply timings

F. Key Relationships

- Indirect reporting into South Korea General Manager

- Works closely with South Korea commercial team to efficiently plan batch release and destruction activities in line with commercial requirements.

- Liaises with Supply Chain Quality Assurance team for monitoring of quality compliance in South Korea

- Key Internal stakeholders include the commercial and customer service, regulatory and Enterprise logistics.

- Key Quality contact for MFDS

G. Decision Making

- Holistic assessment of suitability of product to be supplied into South Korean market

- Recommends final product disposition of products

- Final approval of deviations and change controls relating to affiliate/products to be released into South Korean market

- Plans long lead time activities to ensure no disruption to supply chain (e.g., supplier audits, updates to Quality Agreements)

H. Innovation

- The role holder needs to be able to work with internal and external partners to identify compliant ways to optimize processes for release of products through the affiliate.

I. Travel requirements

- Domestic travel to third parties/service providers expected as part of the role

J. Knowledge, Skills & Competencies

- Fluent in English and Korean

- Strong understanding of and experience in quality assurance systems.

- Strong knowledge of Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), and local regulations and guidelines as applicable to the level of activities carried out at the affiliate or region.

- Sound and balanced judgment; able to assess and handle risks; self-confident, proactive and decisive.

- Able to work and communicate effectively and collaboratively across Affiliate functions and other global Seqirus functions and external partners/3rd parties.

- Good relationship builder and communicator.

- High ethical standards as well as personal credibility.

- Has the expertise, determination and courage to resolve or escalate issues as appropriate, to find innovative solutions in partnership with other functions and to promote a quality culture in the affiliate.

K. Minimum Education Requirements

- Registered Pharmacist

L. Minimum Experience Requirements

- 3-5 years of experience in Quality Management Systems in pharmaceutical industry is preferred

- Knowledge of local regulations in South Korea

- Previous experience with SAP preferred

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Watch our 'On the Front Line' video to learn more about CSL Seqirus

Client-provided location(s): Seoul, South Korea

Job ID: CSL_FGB-R-267557

Employment Type: FULL_TIME

Posted: 2026-01-20T23:31:05