Head of Japan Quality Assurance

Position Purpose:

The purpose of the Local Quality Officer (LQO) 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 CSL Behring (CSLB) Quality within a specific country.

QA (Quality Assurance) Support - QA activities & Management

• Implements and maintains the Local Quality Management System (QMS) in compliance with local regulations and Global CSL Behring standards.
• Enforces the quality management system in all the quality activities of the affiliate. The quality activities include but are not limited to batch release, change control, complaints, and deviation management.
• Provides 3PL vendor oversight, and supports qualification, selection, and negotiation of new suppliers.
• Supports new product launches and ensures compliance of the existing lifecycle products.
• Acts as the primary point of contact to report or liaise about any recalls, field actions, or quality-related supply chain issues with batches delivered to the affiliate or region not meeting requirements.
• Ensures that all relevant affiliate personnel receive initial and ongoing training in compliance with CSL Behring requirements and local regulations.
• Budget control as local level

Local engagement - Cross-functional engagement

• Participates in the local Commercial Operations Leadership Team meetings, monthly business review meetings and provides input to strategic planning and discussions at the local market level.
• As supervisor of the Quality Assurance, one of the three officers, 'SANYAKU' ensure proper quality and safety control of pharmaceutical products.
• Primary point of contact as quality representative of marketing authorization holder in Japan to negotiate and communicate with local external stakeholders as health authorities and customers regarding all quality related issues
• Represents on the CSL Behring Japan Board of directors meeting as the responsible person for Quality as required by local legal requirement in market.
• Key representative to negotiate and discuss supply issues and remediation strategies with Health Authorities and Government Bodies
• Primary point of contact to and from Global or Regional Quality, ensuring a timely, two-way communication above country and in market.
• Collaborates with other local affiliates and Global Quality group to benchmark best quality practices to mature quality culture for the affiliate the LQO is responsible for.
• Serve as deputy for Local/Regional Regulatory Affairs and Local/Regional Pharmacovigilance as assigned and where applicable according to local regulation

Reporting Relationships:

Role that this role reports to:

• Directly to Quality Regional Lead

Role/s that report to this position:

• Quality Assurance Senior Manager Japan
• Senior Quality Associate Japan
• Quality Associates Japan

Main Responsibilities and Accountabilities:

Implementation and maintenance of the Quality Management System in compliance with local regulations and CSLB standards, including but not limited to:

• Maintain local Marketing Authorization License including appropriately respond to relevant regulatory inspections
• Deviation Management
• Corrective Action & Preventive Action (CAPA) Management
• Product Complaints Management
• Change Control Management including Printed Packaging Materials (PPM) management
• Regulatory Compliance Check
• Regulatory related activities (Periodic GMP Inspection management and Foreign Manufacturer Accreditation management)
• Local Supplier Management (3PL and external laboratories)
• 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:

• Responsible to remain compliant for all Quality CSLB products licensed, marketed, or supplied within Territory of responsibility.
• Responsible to stay compliant with local as well as international regulations (e. g. GDP) and maintain inspection readiness.
• Obtain / oversee the legal documentation required license to operate in 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.
• Resolves quality-related issues.

Archives and maintains 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 and local regulations.
• 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.
  • National Assay (including preparation of Summary Lot Protocol)

Contact with Local Regulatory Agency

• Acts as primary contact point to report or liaise with Japan Marketing Authorization Holder if any quality related supply chain issues with batches delivered to the Affiliate / region as not meeting the requested quality criteria

Quality intel.