Global Supplier Quality & Performance Manager - Remote

Otsuka America Pharmaceutical Inc.; Carson City (NV); Remote; USD 108,000 - 161,000; Full time

Benefits offered by this job

Medical benefits

401(k) match

Tuition reimbursement

Paid holidays

Paid leave

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager, Global Supplier Performance & Metrics to lead supplier quality oversight, KPI reporting, and risk management across external suppliers supporting global operations.

This remote, full-time position reports to the Senior Manager and collaborates with Global Quality, Regulatory, Supply Chain, and external partners. Key duties include serving as the quality representative for suppliers, developing dashboards, supporting audits, maintaining

Qualifications

• Bachelor’s degree in a scientific, engineering, or health-related discipline is required.
• Minimum of 3 years of progressive experience within the pharmaceutical, biotechnology, or medical device industry, with experience in Quality Assurance, Supplier Quality, External Manufacturing Quality, or CMO Management.
• Experience supporting supplier quality programs, supplier audits, quality systems, or external manufacturing operations is preferred.
• Experience using TrackWise Digital or comparable eQMS is required.
• Knowledge of FDA 21 CFR Parts 210, 211, and 11, EU GMP, EudraLex Volume 4, and ICH guidelines (Q7, Q9, Q10).
• Experience participating in supplier audits and supporting risk-based supplier management activities.

Responsibilities

• Serve as the primary Quality representative for assigned suppliers, including CMOs, CDMOs, laboratories, packaging suppliers, and other GMP service providers.
• Prepare and present supplier quality performance data in supplier governance meetings, Joint Steering Committees, and Business Review Meetings.
• Build collaborative relationships with supplier quality personnel to enable timely communication, issue resolution, and continuous improvement.
• Identify and escalate supplier quality concerns, performance risks, and compliance issues with recommended actions.
• Collect, maintain, and analyze Global Supplier Quality metrics and KPIs.
• Develop and maintain supplier performance dashboards and scorecards for routine business reviews.
• Prepare recurring supplier performance reports and trend analyses for management.
• Monitor supplier performance data for emerging risks and support mitigation activities.
• Support planning, coordination, and execution of supplier audits for API manufacturers, CMOs, packaging suppliers, and contract laboratories.
• Monitor CAPAs and ensure timely closure.
• Assist with drafting and maintaining supplier Quality Agreements.
• Support supplier qualification and ongoing risk assessment activities.
• Serve as a functional user of TrackWise Digital supplier quality modules and maintain supplier records.

Skills

Analytical thinking

Communication

Stakeholder collaboration

Organizational skills

QA/SQ/CMO experience

Education

Bachelor’s degree in science/engineering/health

3+ years pharmaceutical/biotech/medical device experience

Tools

TrackWise Digital

eQMS

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager, Global Supplier Performance & Metrics to lead supplier quality oversight, KPI reporting, and risk management across external suppliers supporting global operations.

This remote, full-time position reports to the Senior Manager and collaborates with Global Quality, Regulatory, Supply Chain, and external partners. Key duties include serving as the quality representative for suppliers, developing dashboards, supporting audits, maintaining