Remotery

Manager, Global Supplier Performance – Metrics

atOtsuka Pharmaceutical Companies (U.S.)RemoteUS flagUnited StatesFull-timeManagerMid-levelSenior$107.7k – $161k/year

Posted 2 days ago

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the main Quality representative for designated CMOs, CDMOs, laboratories, packaging suppliers, and various GMP service providers.

• Engage in supplier governance meetings, Joint Steering Committees, and Business Review Meetings by preparing and presenting data on supplier quality performance.

• Foster collaborative relationships with supplier quality personnel to enhance communication, resolve issues, and promote continuous improvement.

• Identify and escalate supplier quality issues, performance risks, and compliance concerns along with proposed actions.

• Gather, maintain, and analyze Global Supplier Quality metrics and KPIs.

• Create and sustain supplier performance dashboards and scorecards.

• Compile regular supplier performance reports, trend analyses, and management presentations.

• Track supplier performance data for emerging risks and assist in mitigation efforts.

• Aid in the planning, coordination, and execution of supplier audits.

• Oversee supplier CAPAs and ensure timely follow-up for closure.

• Support in drafting, revising, and maintaining supplier Quality Agreements.

• Assist with supplier qualification and ongoing supplier risk assessment activities.

• Keep supplier profiles, audit records, deviations, CAPAs, and performance documentation organized in TrackWise Digital.

• Ensure that supplier quality records are precise, complete, and ready for inspection.

• Recognize opportunities to enhance supplier quality processes, reporting, and system usage.


⛳️ Requirements

• A Bachelor's degree in a scientific, engineering, or health-related field is mandatory.

• At least 3 years of progressive experience in the pharmaceutical, biotechnology, or medical device sectors.

• Background in Quality Assurance, Supplier Quality, External Manufacturing Quality, or CMO Management.

• Proficient in using TrackWise Digital or similar electronic Quality Management Systems (eQMS).

• Familiarity with FDA 21 CFR Parts 210, 211, and 11.

• Knowledge of EU GMP and EudraLex Volume 4.

• Understanding of relevant ICH guidelines Q7, Q9, and Q10.

• Experience in participating in supplier audits.

• Experience in supporting risk-based supplier management activities.

• Strong analytical skills for interpreting supplier quality metrics and recognizing performance trends.

• Proficient in both written and verbal communication skills.

• Capability to prepare clear reports and present findings to cross-functional teams.

• Ability to cultivate productive working relationships with internal stakeholders and external suppliers.

• Excellent organizational skills and capability to prioritize multiple tasks.

• Capacity to support continuous improvement initiatives.


🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-sponsored basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.

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