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.

Application Deadline: This will be posted for a minimum of 5 business days.

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.

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Otsuka Pharmaceutical Co., Ltd.

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