Associate Director, Global Supplier Quality

Otsuka Pharmaceutical Co., Ltd.

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About The Position

The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company’s global network of contract manufacturing organizations (CMOs). This role supports the qualification, monitoring, and compliance of external manufacturing partners to ensure the quality and reliability of pharmaceutical products, including small molecules and biologics.

Requirements

• Bachelor’s degree in a scientific or engineering discipline.
• 6+ years of experience in pharmaceutical quality, with 2+ years in supplier or external manufacturing quality.
• Strong knowledge of GMP regulations for small molecules and/or biologics.
• Experience conducting audits and managing supplier documentation.
• Strong communication and problem-solving skills.
• Ability to travel internationally as needed.
• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.

Nice To Haves

• Experience working with global CMOs.
• Familiarity with digital tools and systems for supplier management.
• Exposure to regulatory inspections and remediation activities.

Responsibilities

• Support the qualification and ongoing monitoring of CMOs and critical suppliers.
• Execute supplier audits and ensure timely follow-up and resolution of findings.
• Maintain and update quality agreements in collaboration with internal stakeholders.
• Conduct risk assessments and support mitigation plans for supplier-related quality issues.
• Ensure supplier compliance with global regulatory requirements (e.g., FDA, EMA, ICH).
• Prepare documentation and support internal and external audits and inspections.
• Maintain accurate records of supplier performance and audit outcomes.
• Collaborate with Procurement, Manufacturing, Regulatory Affairs, and Technical Operations to ensure supplier quality is integrated into business processes.
• Serve as a point of contact for operational supplier quality issues and escalations.
• Track and report key performance indicators (KPIs) related to supplier quality.
• Provide regular updates to leadership on supplier performance and compliance status.
• May supervise or mentor junior quality staff or contractors.
• Support continuous improvement initiatives within the supplier quality function.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees