Job Description
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
- 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
- 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, ensures 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.
- Serves as deputy for Local/Regional Regulatory Affairs and Local/Regional Pharmacovigilance as assigned and where applicable according to local regulation
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.
Position Qualifications and Experience Requirements:
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 7 years of experience in Quality Management Systems.
- 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
We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.
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