Senior Manager, Global Supplier Quality

The Senior Manager of Global Supplier Quality is responsible for supplier quality management activities that ensure the quality, compliance, performance, and reliability of external suppliers supporting Otsuka’s global development and commercial operations. This role provides technical support for supplier qualification, supplier auditing, supplier risk management, and ongoing supplier oversight activities while partnering with cross-functional stakeholders to strengthen supplier quality processes, proactively manage supplier quality risks, and support continuous improvement across the Global Supplier Quality program.

• Support quality oversight activities for strategic and high-risk suppliers supporting commercial and development operations.
• Partner with Procurement, Supply Chain, Manufacturing, Technical Operations, Regulatory Affairs, and Quality organizations to support supplier lifecycle activities.
• Support supplier governance activities through routine quality interactions, supplier performance reviews, and risk assessments.
• Build collaborative relationships with suppliers while maintaining compliance with Otsuka quality standards and applicable regulatory requirements.

• Support domestic and international GMP audits of contract manufacturers (CMOs/CDMOs), contract laboratories, API manufacturers, packaging suppliers, distributors, and other outsourced GxP service providers.
• Support execution of the global supplier audit program to ensure timely completion of risk-based supplier audits.
• Review audit reports to ensure consistency, technical accuracy, and compliance with established audit procedures.
• Review supplier responses and CAPA plans to ensure audit observations are effectively addressed.
• Support evaluation of supplier quality issues and recommend actions to management.
• Support regulatory inspections and inspection readiness activities involving supplier quality.

• Monitor supplier quality performance and identify emerging trends and quality risks.
• Support development and reporting of supplier quality metrics and key performance indicators.
• Recommend actions to mitigate supplier quality risks and improve supplier performance.
  
  Escalate significant supplier quality risks and compliance concerns, as appropriate.

• Recommend continuous improvement initiatives that strengthen supplier quality processes, audit effectiveness, and operational efficiency.
• Support optimization of electronic Quality Management Systems, including Track Wise Digital.
• Support development and revision of supplier quality procedures, work instructions, templates, and training materials.
• Identify opportunities to improve consistency across supplier quality processes and audit activities.

• Provide guidance and support to colleagues and auditors within assigned areas of expertise.
• Participate in and support cross-functional projects and supplier quality initiatives.
• Develop and maintain expertise in supplier auditing, supplier risk management, and external supplier oversight.
• Contribute to knowledge sharing, and continuous improvement across the Global Supplier Quality organization.

• Bachelor’s degree in Biology, Chemistry, Engineering, Pharmacy, or another scientific discipline.
• Minimum of 6 years of progressive experience in Quality Assurance, Supplier Quality, External Manufacturing Quality, Manufacturing Quality, or Quality Systems within the pharmaceutical, biotechnology, or medical device industry.
• Minimum of 3 years of experience independently planning, conducting, and leading GMP audits of external suppliers.
• Strong knowledge of FDA, EMA, ICH, and other applicable global GMP regulations.
• Experience leading complex supplier quality activities including supplier qualification, supplier oversight, audit observations, CAPA management, supplier risk assessments, and supplier performance monitoring.
• Demonstrated ability to support supplier activities, collaborate with cross-functional stakeholders, and contribute to quality improvement activities.
• Strong communication, analytical, organizational, and problem-solving skills with the ability to influence cross-functional stakeholders.
• Ability to travel domestically and internationally, up to 50%.

• ASQ Certified Quality Auditor (CQA), Lead Auditor certification, or equivalent.
• Experience supporting commercial and development-stage…