Global Supplier Quality Specialist

Dexian; Addison (TX); On-site; USD 110,000 - 140,000; Full time

Job summary

Dexian, a global talent + technology solutions provider, seeks a Senior Supplier Quality professional to support Corporate Quality and Global Supplier Quality Management in a GMP-regulated setting. The role emphasizes supplier qualification, audits, CAPA/SCAR, risk management, and supplier performance oversight.

You will collaborate with Procurement, Regulatory Affairs, Manufacturing, R&D, Quality Systems, Product Integrity, and Operations, help prepare for FDA inspections, and drive quality

Qualifications

• 5+ years of experience in Supplier Quality, Quality, Engineering, or Manufacturing.
• Experience in a GMP-regulated environment.
• Experience in pharmaceutical, OTC, personal care/cosmetics, nutritional, or dietary supplement industries preferred.
• 3+ years of audit experience, including supplier/external audits.
• Strong experience with Supplier Quality Management, supplier qualification, CAPA/SCAR, and corrective actions.
• Knowledge of GMP, FDA regulations, quality systems, and audit requirements.
• Strong communication and cross-functional collaboration skills.
• Ability to work independently in a global/matrix organization.

Responsibilities

• Manage supplier qualification, approval, and ongoing supplier oversight.
• Conduct risk-based supplier assessments and determine appropriate audit requirements.
• Plan, conduct, and report supplier, vendor, CMO, and external audits.
• Review audit findings and ensure timely closure of identified gaps.
• Manage supplier CAPA, SCAR, corrective actions, and effectiveness verification.
• Handle supplier-related quality events, deviations, nonconformances, complaints, and material issues.
• Monitor supplier performance through KPIs, scorecards, metrics, escalation, and business reviews.
• Support creation, review, renewal, and maintenance of Quality Agreements / Technical Quality Agreements.
• Evaluate supplier-related changes involving materials, manufacturing sites, processes, and suppliers.
• Assess supplier quality and regulatory risks associated with changes.
• Collaborate with Procurement, Regulatory Affairs, Manufacturing, R&D, Quality Systems, Product Integrity, and Operations.
• Support FDA and other regulatory inspections and audit activities.
• Represent Corporate Quality on new product development and cross-functional teams.

Skills

Supplier Quality Management

Audit facilitation

Cross-functional collaboration

GMP knowledge

Quality systems

Education

Bachelor's degree in STEM or related discipline

Tools

SAP

JDE

TrackWise

Veeva

LIMS

eQMS

PLM/ERP systems

Job description

Dexian, a global talent + technology solutions provider, seeks a Senior Supplier Quality professional to support Corporate Quality and Global Supplier Quality Management in a GMP-regulated setting. The role emphasizes supplier qualification, audits, CAPA/SCAR, risk management, and supplier performance oversight.

You will collaborate with Procurement, Regulatory Affairs, Manufacturing, R&D, Quality Systems, Product Integrity, and Operations, help prepare for FDA inspections, and drive quality