Global Supplier Quality Lead: GMP Audits & Risk

Otsuka Pharmaceutical Co., Ltd; United States; Remote; USD 135,000 - 201,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Prescription drug coverage

Basic life insurance

AD&D insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Other benefits

Job summary

Otsuka Pharmaceutical Co., Ltd. is seeking a Senior Manager of Global Supplier Quality to oversee supplier quality management for global development and commercial operations.

You will provide technical support for supplier qualification, audits, risk management, and oversight, partnering with cross‑functional stakeholders to strengthen processes and manage quality risks. You will drive supplier governance, review audit outcomes, CAPA plans, and regulatory inspection readiness, while leading

Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, Pharmacy, or another scientific discipline.
• Minimum of 6 years of progressive QA, supplier, external manufacturing, or quality systems experience in pharma/biotech/medical devices.
• Minimum of 3 years independently planning, conducting, and leading GMP audits of external suppliers.

Responsibilities

• Oversee supplier quality activities for strategic/high‑risk suppliers supporting commercial and development ops.
• Collaborate with Procurement, Supply Chain, Manufacturing, R&D, Regulatory, and Quality to support supplier lifecycle activities.
• Review audit reports and CAPA plans to ensure observations are addressed and compliance maintained.
• Manage supplier performance reviews, risk assessments, and escalation of significant quality risks as needed.
• Lead continuous improvement initiatives to strengthen supplier quality processes and audit effectiveness.

Skills

Quality Assurance

GMP Audits

Supplier Quality

Regulatory Knowledge

Cross-functional Collaboration

Travel up to 50%

Education

Science degree

Tools

TrackWise Digital

GxP systems

Job description

Otsuka Pharmaceutical Co., Ltd. is seeking a Senior Manager of Global Supplier Quality to oversee supplier quality management for global development and commercial operations.

You will provide technical support for supplier qualification, audits, risk management, and oversight, partnering with cross‑functional stakeholders to strengthen processes and manage quality risks. You will drive supplier governance, review audit outcomes, CAPA plans, and regulatory inspection readiness, while leading