Senior Manager, Global Supplier Quality

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Manage quality oversight activities for strategic and high-risk external suppliers supporting commercial and development operations • Partner with Procurement, Supply Chain, Manufacturing, Technical Operations, Regulatory Affairs, and Quality organizations on supplier lifecycle activities • Conduct supplier performance reviews, risk assessments, and supplier governance activities • Support domestic and international GMP audits of contract manufacturers, laboratories, API manufacturers, packaging suppliers, distributors, and outsourced GxP providers • Execute the global, risk-based supplier audit program and review audit reports for accuracy and compliance • Review supplier responses and CAPA plans and evaluate supplier quality issues • Support regulatory inspections and inspection readiness involving supplier quality • Monitor supplier quality performance, metrics, KPIs, trends, and emerging risks • Recommend risk mitigation and supplier performance improvement actions and escalate significant concerns • Recommend continuous improvements to supplier quality processes, audit effectiveness, and operational efficiency • Support optimization of electronic Quality Management Systems, including TrackWise Digital • Develop and revise supplier quality procedures, work instructions, templates, and training materials • Guide colleagues and auditors, participate in cross-functional projects, and contribute to knowledge sharing and continuous improvement

🎯 Requirements

• 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 • Experience must be 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 with supplier qualification, supplier oversight, audit observations, CAPA management, supplier risk assessments, and supplier performance monitoring • Ability to support supplier activities and collaborate with cross-functional stakeholders • Strong communication, analytical, organizational, and problem-solving skills • 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 preferred • Experience supporting commercial and development-stage pharmaceutical products preferred • Experience utilizing TrackWise Digital preferred • Experience supporting regulatory inspections and supplier remediation activities preferred • Experience developing or improving supplier quality processes, supplier audit programs, or supplier governance activities preferred

🏖️ Benefits

• Incentive opportunity • Comprehensive medical coverage • Dental coverage • Vision coverage • Prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term disability insurance • Long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits