Associate Quality Director, External Quality

AstraZeneca

. Manage Quality for assigned External Suppliers within Procurement Quality AsiaPac teams .

Posted 9/29/2026full-timeOsaka • JapanLeadWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Quality Management Systems, cGMPs, and regulatory compliance within the pharmaceutical supply chain. Proficient in managing supplier quality assessments and leading cross-functional improvement initiatives.

Highest-signal resume keywords

Quality Management SystemsCGMP KnowledgeRegulatory Agency InteractionProject Management SkillsSupplier Quality Assessment

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Quality System OversightChange ControlDeviation InvestigationPharmaceutical Quality AssuranceProcess OptimizationSupplier Quality ManagementPharmacopeia StandardsISO StandardsQuality AgreementsNPI Leadership

Soft Skills

Excellent Communication SkillsProblem-Solving SkillsNegotiating SkillsInfluencing SkillsAbility to Work Independently

Certifications & Qualifications

Bachelor's Degree in Science/Technical FieldTOEIC 800+Japanese Language N1 Level

Industry Keywords

Pharmaceutical Supply ChainQuality AssuranceExternal SuppliersRegulatory ComplianceQuality Improvement Initiatives

About the role

Key responsibilities & impact

Manage Quality for assigned External Suppliers within Procurement Quality AsiaPac teams
Execute Quality Management of Suppliers for assigned suppliers
Provide Quality System oversight and/or perform change control, product quality complaint, S&L complaint and deviation investigations
Manage quality issues and escalations
Establish and maintain Quality Agreements between AstraZeneca and External Suppliers and between External Quality and AstraZeneca Operations Sites
Oversee and own Quality Systems within the External Quality organization
Support Quality Professionals involved in Quality Supplier and Product Supply Chain Management
Prepare and submit periodic Supplier Quality Assessments
Interact with Regulatory Agencies
Serve as Quality leader on NPI, new supplier introductions, in-licensing, strategic sourcing, process optimization, and product transfer projects
Prepare for and manage Regulatory Agency inspections at External Suppliers and AstraZeneca sites when External Suppliers are assessed

Requirements

What you’ll need

Strong demonstrated knowledge of cGMPs, Quality Systems, and the pharmaceutical supply chain environment
Strong understanding of industry standards such as Pharmacopeia and ISO standards
Excellent oral and written communication skills in English and local language(s)
Demonstrated experience working cross-functionally and managing significant improvement initiatives, including project management skills
Strong problem-solving skills
Strong negotiating/influencing skills
Ability to work independently under own initiative
Bachelor's degree in a science/technical field such as Pharmacy, Biology, Chemistry, or Engineering
Proven broad experience in the pharmaceutical operations environment or pharmaceutical Quality Assurance role
Japanese language at N1 level
English language at TOEIC 800+
Ability to travel nationally and internationally as required, approximately 10% of time

Benefits

Comp & perks

Ability to travel nationally and internationally as required, approximately 10% of time
Full-time employment