Quality Assurance Representative

Job Summary:

The Global Supplier Quality Management (GSQM) Contractor is responsible for executing the GSQM Program to support Client’s new site expansions. This role ensures timely onboarding of suppliers, materials, and GMP service providers by partnering with Supply Chain, Affiliates, and cross-functional teams. The contractor acts as a central resource to ensure globally consistent Supplier Quality Management processes that uphold patient safety, product quality, and regulatory compliance.

Key Responsibilities

• Supplier Quality & Compliance
• Execute Supplier Quality Management processes in compliance with Global Quality Standards (GQS305, GQS301, GQS307, and others as applicable).
• Assist Procurement, Supply Chain, GQAAC, MMQA, TS/MS, and Manufacturing teams in identifying and managing material suppliers and GMP service providers.
• Support supplier-related change controls and ensure proper documentation and process alignment.
• System Execution & Data Management
• Perform SAP and TW138 activities for the Approved Supplier List (ASL) for site expansions; collaborate with SAP Business QA as needed.
• Maintain accurate supplier quality data in systems such as SAP, Veeva Vault (QDocs), and TrackWise.
• Support Certification Package Review Boards and manage global certification packages for SAP Manufacturing Plants.
• Communicate and collaborate with global manufacturing and affiliate sites (API, Packaging, Devices, etc.) to ensure robust process execution and escalate barriers when necessary.
• Partner with Global TS/MS to develop and implement material risk control strategies—including material risk, product acceptance, and specification controls.
• Develop and communicate process updates and GSQM-related initiatives.
• Personal Development
• Stay updated on industry trends and regulatory expectations related to GMP/cGMP and Supplier Management.
• Maintain strong interpersonal, verbal, and technical writing skills.
• Complete all required training and qualifications via the Learning Plan.

Qualifications:

Required

• Associate’s degree or equivalent advanced training.
• Strong knowledge of manufacturing operations, quality systems, and supplier quality management.
• Experience with SAP, TrackWise, and Veeva QualityDocs preferred.
• Experience in Change Management.
• Proficiency in MS Office (Teams, OneNote, OneDrive, SharePoint, PowerPoint, Excel).
• Excellent communication skills with the ability to provide constructive feedback and collaborate effectively.
• Strong problem-solving and strategic thinking abilities.
• Ability to work independently and within a team environment.

Preferred

• Minimum 5 years’ experience in a QA role at a manufacturing site.
• Knowledge of Quality Management, Supplier Quality Management, ISO standards, and GMPs.
• Experience with PowerApps, Power BI, or Tableau.
• Familiarity with GQS, CQP, and LQP frameworks.

Additional Information:

• May require visits to Client manufacturing sites.
• Must have strong English verbal and written communication skills.