Position Purpose:

• To lead Quality Assurance group developing talents
• To operate appropriately quality events in compliance with global CSLB policies and local regulatory requirements
• To collaborate with internal partners, such as global Quality Assurance, global manufacturing sites and local other departments (regulatory affairs, logistic and supply planning)
• To communicate with the local health authorities (MHLW, PMDA, NIID and TMG) and external parties regarding quality related issues
• To establish simplified and standardized governance model in accordance with the global policy

Reporting Relationships:

Report line: Head of Quality Assurance Department

Subordinates that report to this position: TBD

Main Responsibilities and Accountabilities:

1 To Lead Quality assurance group and Perform routine quality-related activities (product release, deviation and complaint handling, CAPA, change control and recall) in compliance with global policies and local regulatory requirements

2 To Collaborate with internal partners

• Global Quality Assurance: to introduce global policy standards
• Global Manufacturing Sites: to solve quality related issues and make ensure stable supply without significant quality / regulatory issues
• Regulatory Affairs: to establish and implement the submission strategy
• Logistics and Supply Planning: to make ensure stable supply without significant quality / regulatory issues
• Sales and Marketing: to support stable commercial operations

3 To Communicate with Health Authorities (MHLW, PMDA, NIID and TMG) and external parties (3PL and external laboratories)

4 To Develop talent and skill in team

5 To Establish simplified and standardized governance model in accordance with the global policy

6 To Oversee projects (new product launch and packaging improvement)

Position Qualifications and Experience Requirements:

Education

• Bachelor degree or equivalent degree holder, such as chemical, biochemical or pharmacy (preferable)
• Advanced level in English

Experience

• People management (1 - 5 lines)
• Experiences in GxP (preferable; GMP and GQP) fields within pharmaceutical industry

Competencies

• Good interpersonal skills (Collaboration, Reliability, Leadership, Positivity, Negotiation, Teamwork, Innovation and Transparency)
• Foster engaged and inclusive culture

Our Benefits

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.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!