Remote
Full time
R12737
Otsuka is seeking a highly motivated, results-driven, and analytical professional to serve as the Senior Manager of Global Supplier Performance & Metrics. Reporting directly to the Associate Director, Global Supplier Performance & Metrics, this role is responsible for driving the day-to-day execution of supplier quality management strategies to ensure the quality, compliance, and reliability of external suppliers supporting Otsuka's global operations.
The position partners closely with Global Quality, Technical Operations, Supply Chain, and external suppliers to maintain a robust supplier quality framework aligned with global GMP, GDP, and applicable regulatory requirements.
Key Responsibilities
1. Supplier Oversight & Operational Relationship Management
Relationship Execution: Serve as a primary Quality point of contact for assigned critical external suppliers, contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs).
Quality Business Reviews: Support Joint Steering Committees and Business Review Meetings. Deliver and present data-driven quality insights to ensure supplier operational decisions align with GMP compliance and Otsuka standards.
Collaborative Accountability: Partner directly with supplier quality counterparts to monitor performance, address deviations early, and proactively prevent quality failures.
2. Data Analytics, KPIs, & Performance Reporting
Metric Tracking & Dashboarding: Own the day-to-day collection, tracking, and analysis of standardized Global Supplier Quality metrics and KPIs. Maintain performance dashboards.
Management Reports: Synthesize complex data sets into concise, clear quality performance reports. Draft presentations and updates for the Associate Director to support management-level decision-making.
Trend Analysis: Monitor data for negative trends in supplier performance, escalating risks to leadership and executing approved mitigation strategies to safeguard global product supply.
3. Supplier Qualification & Auditing Execution
Audit Execution: Coordinate and execute assigned audits within the global supplier audit schedule, ensuring robust evaluation of API manufacturers, drug product CMOs, packaging suppliers, and laboratories.
Quality Agreements: Assist with the drafting, initial negotiation, and maintenance of global Quality Agreements, ensuring regulatory expectations and roles are clearly defined.
TrackWise Digital Power User: Act as a hands-on support for TrackWise Digital supplier quality modules. Manage daily utilization including supplier profiles, audit logging, deviations, and CAPA 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.
Industry Experience: A minimum of 5 years of progressive experience within the pharmaceutical, biopharmaceutical, or medical device industry, with a strong focus on quality assurance, supplier quality, or CMO management.
Technical & Software Skills
Digital Proficiency: Hands-on experience with TrackWise Digital is strictly required. Must possess deep proficiency in navigating, leveraging, and managing workflows/dashboards within the platform.
Regulatory Expertise: Knowledge of global GxP regulations (FDA 21 CFR 210/211/11, EU GMP, EudraLex Volume 4, ICH guidelines Q7, Q9, Q10).
Audit Capabilities: Proven track record executing supplier audits as a lead or co-auditor, utilizing risk-based auditing methodologies.
Soft Skills & Core Competencies
Analytical Skills: Strong capability to compile large data sets, identify systemic trends, and translate metrics into clear, actionable visual reports.
Communication & Presentation: Excellent written and verbal communication skills, with the ability to confidently present data summaries and risk assessments to management.
Collaboration & Problem Solving: Demonstrated ability to manage difficult conversations with external suppliers, successfully balancing regulatory compliance with healthy, collaborative business relationships.
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 $134,615.00 - Maximum $201,250.00, 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://ah-prod.com/multi/videoplayer/player.html?v=6385356920112 .
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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 [email protected] .
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