Specialist Corporate Quality

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

This role will support Corporate Quality and Global Supplier Quality Management by ensuring external suppliers, manufacturers, and service providers meet applicable GMP, regulatory, and company quality requirements.

The position will focus heavily on Supplier Quality Management, supplier qualification, supplier audits, CAPA/SCAR, supplier performance, risk management, Quality Agreements, and supplier change control.

Key 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.

Required Qualifications:

• Bachelor's degree in STEM or a related scientific/technical discipline.
• 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.

Preferred Technical Experience:

• SAP
• JDE
• TrackWise
• Veeva
• Agile
• LIMS
• eQMS
• PLM/ERP systems

Knowledge of ICH Q7, ICH Q9, ICH Q10, 21 CFR Part 11, 21 CFR Part 111, 210, and 211 is beneficial.

ASQ certification or equivalent is required, such as:

• Certified Quality Auditor (CQA)
• Certified Quality Engineer (CQE)
• Certified Pharmaceutical GMP Professional (CPGP)
• Certified Food Safety Quality Auditor (CFSQA)

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals.To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.