Want to know if this job is worth applying to?
日本
Onsite
We are seeking an experienced Senior Quality Assurance Manager to lead and maintain our local Quality Management System, ensuring compliance with local regulations and global CSL Behring standards. This role is responsible for driving quality excellence across the affiliate, providing strategic quality leadership, supporting product lifecycle activities, managing supplier oversight, and partnering cross-functionally with local, regional, and global stakeholders to foster a strong quality culture and ensure the highest standards of patient safety and product quality.
Reporting to QA Head Japan
Roles & Responsibilities
Implementation and maintenance of the Quality Management System in compliance with local regulations and CSLB standards, including but not limited to: Deviation Management o Corrective Action & Preventive Action (CAPA) Management, Product Complaints Management, Change Control Management, Documentation Management, Training Management, Recall Management, Self-Inspection Management, Quality Risk Management and recommendation for improvements to the quality system supporting CSLB business in the countries
Implementation of the Quality Systems in daily operations: Quality responsibility for all CSLB 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 license to operate in the Territory, Maintain up-to-date Quality Agreements, Develop, implement, and maintain local Quality procedural documentation (in accordance with Global policies and procedures and the local document management system, if required), Monitor performance indicators related to quality compliance, Resolve quality-related issues, Archive and maintain all quality documents in line with CSLB procedures and legal requirements
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
Product Recalls & Field actions Management: Acts as Affiliate Recall Coordinator and promptly performs any recall operations for all CSLB distributed products according to CSLB procedures, Coordinates with marketing authorization holders and national competent authorities in the event of recalls, Supports as required in the event of a field action, as determined by the Supply Chain Incident Management Team (SCIMT)
Product Returns Management: Ensures product returns are managed efficiently, Responsible on the final disposition of returned products, Approves any returns to saleable stock where acceptable according to CSLB procedures and local regulatory policy
Verification of Suppliers and Customer Status: Ensures that only qualified GMP/GDP-relevant suppliers, vendors and customers are used
Management of Unlicensed Products: Ensures that any additional requirements imposed on certain products by national/regional law are adhered to e.g. specials, unlicensed imports
Final administrative release of all product batches: Ensures all batch documentation and transportation documents are available and compliant with local/regional requirements to make a final decision on whether or not to release in SAP
Contact with Local Regulatory Agency: Acts as primary contact point to report or liaise with distributors if any quality related supply chain issues with batches delivered to the Affiliate/region as not meeting the requested quality criteria
Quality intelligence: Ensures local regulatory information related to quality topics and assess impact for CSLB activities
Health Authority Inspections: Host the Health Authority where applicable for routine inspections, Support CSL overseas manufacturing sites with MFDS inspections.
Qualifications, Skills & Experience
Degree in pharmacy or life science (if required by local legislation) or equivalent experience
At least 10 years of experience in the pharmaceutical industry, of which 5 years of experience in Quality Management Systems
Fluent in local language and good knowledge of oral and written English
Understands and has experience in pharmaceutical quality assurance systems
Knowledge of Good Distribution Practices (GDP), Good Manufacturing Practices (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
Works and communicates effectively and collaboratively across affiliate functions and other global CSL functions and external partners or third parties
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
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.