Senior Manager, Global Supplier Performance, Metrics

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

📋 Description

• Act as the main Quality liaison for designated critical external suppliers, Contract Manufacturing Organizations (CMOs), and Contract Development and Manufacturing Organizations (CDMOs).

• Facilitate Joint Steering Committees and Business Review Meetings.

• Deliver data-driven quality insights that adhere to Good Manufacturing Practice (GMP) compliance and Otsuka's standards.

• Oversee supplier performance, promptly address deviations, and proactively mitigate quality failures.

• Gather, monitor, and analyze Global Supplier Quality metrics and Key Performance Indicators (KPIs).

• Maintain dashboards for supplier performance.

• Transform complex data into quality performance reports and management presentations.

• Track negative trends in supplier performance, escalate risks, and implement mitigation strategies.

• Organize and conduct assigned supplier audits.

• Aid in drafting, negotiating, and managing global Quality Agreements.

• Support daily operations in TrackWise Digital related to supplier quality, including managing supplier profiles, audit logging, deviations, and Corrective and Preventive Action (CAPA) tracking.

⛳️ Requirements

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

• At least 5 years of progressive experience within the pharmaceutical, biopharmaceutical, or medical device sectors.

• A strong emphasis on quality assurance, supplier quality, or CMO management.

• Direct experience with TrackWise Digital is a strict requirement.

• Advanced proficiency in navigating, utilizing, and managing TrackWise Digital workflows and dashboards.

• Familiarity with global Good Practice (GxP) regulations, including FDA 21 CFR 210/211/11, EU GMP, EudraLex Volume 4, and ICH Q7, Q9, Q10 guidelines.

• Demonstrated experience conducting supplier audits as a lead or co-auditor.

• Experience in applying risk-based auditing methodologies.

• Strong capability to compile extensive data sets, identify systemic trends, and convert metrics into actionable visual reports.

• Exceptional written and verbal communication skills.

• Ability to present data summaries and risk assessments effectively to management.

• Skillful in handling challenging conversations with external suppliers while maintaining regulatory compliance and fostering collaborative relationships.

🏝️ Benefits

• Incentive opportunity.

• Comprehensive medical coverage.

• Dental coverage.

• Vision coverage.

• Prescription drug coverage.

• Company-provided basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term disability insurance.

• Long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) match.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Other company-provided benefits.