Key Responsibilities
Lead and manage GQP operations, including:
Release control
Manufacturing site oversight
Quality information and change control
Quality agreements
Training and self-inspections
Recalls
Document and record management
Provide guidance and collaborate with subcontractors:
Explain Japanese regulatory requirements
Conduct audits and manage deviations and changes
Collaborate with global QA and supply chain teams:
Adapt global policies for Japan
Share Japan-specific quality needs with global teams
Develop improved SOPs in collaboration with global counterparts
Support new product introductions:
Work with new CMOs
Prepare for GMP inspections
Respond to PMDA inquiries
Create product quality standards and related documentation
Contribute to the establishment and operations of a new MAH QA department focused on biologics
Manage license renewals and maintain compliance for marketing and manufacturing authorizations
Requirements
5+ years of experience in GQP/GMP QA within a pharmaceutical company
Solid understanding of Japanese pharmaceutical quality regulations (GQP/GMP)
Experience working with MAHs or as QA contact for manufacturing sites
Business-level English proficiency
Strong communication skills for working with internal teams and external partners
Ability to lead cross-functional projects and build strong working relationships
Preferred Attributes
Passion for improving patient outcomes through quality healthcare products
Strong scientific mindset with attention to detail and high standards
Team player who values collaboration and diversity
Proactive and adaptable in dynamic environments
Experience with antibody drugs or other biologics is a plus
Enjoys working in a fast-paced setting and brings a positive, can-do attitude