Manager/senior Manager, Distribution And Regional Quality, Japan
BeiGene
Japan
Gqp and gdp guidance compliance
In-country disposition/release activities
Gqp sop creation and maintenance
Ensure compliant and uninterrupted supply of BeOne products in accordance with BeOne’s quality management system and expectations from Japanese health authorities
Job Summary
Ensure compliant and uninterrupted supply of BeOne products in accordance with BeOne’s quality management system and expectations from Japanese health authorities.
Collaborate with colleagues in Quality to manage external audits, complaints, deviations, recalls, counterfeits, and product tampering.
BeOne offers a market-competitive compensation package, company shares, and in-house and external learning and development opportunities.
Matching Summary
Ensure compliant and uninterrupted supply of BeOne products in accordance with BeOne’s quality management system and expectations from Japanese health authorities.
Skills & Requirements
Must-have
GQP and GDP guidance compliance
In-country disposition/release activities
GQP SOP creation and maintenance
Complaint management processes
Change control management
Third-party provider audits/evaluations
Nice-to-have
Collaborative team environment
Passionate interest in fighting cancer
Highly motivated professionals
Entrepreneurial mindset
Results-oriented
Key Requirements
Bachelor degree or Science degree
Experience with GQP Ordinance
Experience with GDP guidance
Experience with Marketing Authorization Holder
Experience with investigational medical product qualification