Senior Supplier Quality Specialist

Elevate your pharmaceutical career by joining a globally recognized company renowned for its innovative treatments and outstanding employee satisfaction. With a robust portfolio, our client is in great standing with the FDA and has received positive audits from international regulatory bodies.

Our client is seeking a dedicated professional to manage commercial Supplier Quality Management activities. This includes executing pharmaceutical vendor audits, overseeing quality agreements, lifecycle management, and handling changes and complaints to external vendors.

Apply to this ad or reach out to Jessica Goodman if you ready to join a team where employees thrive.

*This is a hybrid position (3 days onsite, 2 WFH) and requires up to 30% domestic and international travel.

Responsibilities:

• Supplier Quality Management of commercial materials and pharmaceutical service providers
• Lead external audits, write associated audit reports, and follow-up on actions related to audits observations
• Evaluate change control records and manage supplier change notifications
• Coordinate Quality Agreements both new and periodic reviews
• Perform risk assessments and associated risk mitigation plans
• Coordinate supplier nonconformance investigations with vendors
• Notifies management of any atypical trend observed in the quality systems
• Develop Standard Operating Procedures and other quality related documents
• Review and approve written procedures and other documents
• Interact with vendors and plant personnel to insure CGMP compliance
• Provide support to projects, metrics and other quality systems
• Serves as a Subject Matter Expert, and support activities in the area

Requirements:

• 8+ years of experience in a Quality Assurance role in the pharmaceutical industry
• Broad experience performing supplier audits

Preferred Qualifications:

• Auditor certification preferred

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