Global Product Quality Specialist II

Global Product Quality Specialist

12-month contract

Remote EST hours, travel required for audits (2-3 times per month)

The Global Product Quality Specialist supports Supplier Quality and Global Quality operations through audit management, vendor oversight, compliance activities, and quality systems support within a GMP-regulated environment. This role partners cross-functionally with internal teams, suppliers, affiliates, and external auditors to ensure compliance with internal quality standards and global regulatory requirements.

Responsibilities

• Support Global Product Quality and Supplier Quality initiatives, including inspections, audit programs, and global compliance activities
• Coordinate and maintain internal and external audit schedules to ensure timely completion of required audits
• Perform and support supplier and external audits as needed
• Track audit status, follow up with auditors, and ensure completion of audit-related activities
• Maintain Audit Plans, Approved Supplier Lists, and vendor data within TrackWise and related Quality Management Systems
• Support vendor management activities including risk assessments, vendor deviations, audit observations, CAPAs, and Quality Agreements
• Provide updates to global quality databases related to contracts and supplier agreements
• Compile and report KPIs, audit metrics, and compliance data related to outsourced GMP activities
• Support Quality Management System (QMS) projects, regulatory compliance initiatives, process improvements, and training documentation
• Collaborate with global cross-functional teams to ensure compliance with GMP/GxP requirements and internal quality standards

Qualifications

• Bachelor’s degree required
• 4–7 years of Quality experience within a regulated industry
• Minimum 3 years of auditing experience
• Experience in GMP/GxP environments required
• Experience with supplier/vendor quality management preferred
• Familiarity with TrackWise or similar QMS platforms preferred
• Strong organizational, communication, and project coordination skills

Preferred Background

• Pharmaceutical, biotechnology, medical device, or regulated manufacturing industry experience
• Supplier Quality, Vendor Quality, QA Compliance, or Quality Systems experience
• Experience supporting internal/external audits, CAPAs, deviations, and regulatory inspections