Job Description

Otsuka is seeking a dynamic, strategic, and experienced individual to serve as the Associate Director of Global Supplier Performance & Metrics. The role is responsible for leading execution of supplier quality management strategies that ensures the quality, compliance, performance, and reliability of external suppliers supporting Otsuka's global development and commercial operations. This role serves a key quality role assisting with supplier management activities (qualification, audits, risk management, and compliance oversight) and overseeing supplier performance oversight activities (KPIs, supplier scorecards, governance, relationship management, and executive reporting). This role goes beyond traditional compliance oversight to bridge the gap between technical quality assurance, data-driven performance management, and strategic relationship building.

The position partners closely with Global Quality, Technical Operations, Supply Chain, Regulatory Affairs, and external suppliers to establish and maintain a robust supplier quality framework aligned with global GMP, GDP, and applicable regulatory requirements. This leader is responsible for managing critical supplier relationships, driving continuous improvement initiatives, developing supplier quality metrics, and providing management-level insights regarding supplier quality performance, risks, and mitigation strategies.

Key Responsibilities

1. Strategic Supplier Oversight & Relationship Management

· Critical Relationship Governance: Serve as the primary Global Quality lead for Otsuka’s tier-one and identified critical external suppliers, contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs).

· Quality Business Reviews: Partner with Global Procurement and Supply Chain to assist with regular Joint Steering Committees and Business Review Meetings. Inject a firm, data-driven quality scope into these meetings to ensure operational decisions align with GMP compliance and Otsuka standards.

· Relationship Building: Foster a culture of collaborative accountability with suppliers, implementing a strategic partnership that proactively prevents quality issues or failures.

2. Data Analytics, KPIs, & Executive Readouts

· Metric Architecture: Contribute to the development, implementation, and tracking of standardized Global Supplier Quality metrics, dashboards, and KPIs (e.g., Right-First-Time, Supplier OOS rates, CAPA efficacy, audit cycle times).

· Management Readouts: Synthesize complex data sets into concise, high-level quality performance presentations and provide supplier quality performance updates and insights to management. Partners with senior stakeholders to support decision-making

· Predictive Risk Modeling: Use quality metrics to identify negative trends in supplier performance, initiating preemptive mitigation strategies before they impact global product supply.

3. Supplier Management & Auditing

· Audit Lifecycle Management: Oversee the execution of the global supplier audit schedule, ensuring robust evaluation of active pharmaceutical ingredient (API) manufacturers, drug product CMOs, packaging suppliers, and critical laboratories.

· Quality Agreements: Assist with the negotiation, drafting, and maintenance of comprehensive global Quality Agreements that clearly define roles, responsibilities, and regulatory expectations.

· System Ownership: Champion the optimization and daily utilization of TrackWise Digital for all supplier quality modules, including supplier profiles, audit logging, deviations, and associated findings tracking.

Requirements & Qualifications

Education & Experience

· Degree: Bachelor’s degree in a scientific, engineering, or health-related discipline ( e.g., Chemistry, Biology, Pharmacy, etc.) is required. An advanced degree (MS, MBA) is preferred.

· Industry Experience: A minimum of 8 years of progressive experience within the pharmaceutical, biopharmaceutical, or medical device industry, specifically focused on quality assurance, supplier quality, or CMO management required.

· Leadership Experience: Minimum of 5 years of direct managerial experience managing, developing, and evaluating quality professionals in a global or matrixed environment.

Technical & Software Skills

· Digital Proficiency: Hands-on experience with TrackWise Digital is strictly required. Proficiency in navigating, configuring, or leveraging the platform for supplier quality workflows, tracking, and dashboarding.

· Regulatory Expertise: Knowledge of global GxP regulations (FDA 21 CFR 210/211/11, EU GMP, EudraLex Volume 4, ICH guidelines Q7, Q9, Q10).

· Audit Mastery: Certification or proven track record exhibiting lead auditor capabilities, with deep knowledge of risk-based auditing methodologies and practices.

Soft Skills & Core Competencies

· Analytical Capabilities: Advanced ability to compile data, identify systemic trends, and build clear data visualizations for management consumption.

· Executive Presence: Exceptional communication skills with a proven track record of delivering concise, persuasive quality performance readouts to management.

· Conflict Resolution & Negotiation: Demonstrated ability to handle difficult conversations with critical external suppliers, striking a balance between strict compliance enforcement and maintaining a collaborative business relationship.

Competencies
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.

Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Company 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.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka

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