Associate, Global Product Quality Materials

Job Summary

Every life-saving drug starts with raw materials. Join our global quality team to own the supplier onboarding pipeline, tackle material change controls, and ensure our supply chain is completely bulletproof before manufacturing ever begins.

Responsibilities

• Assist the material supplier management process for all raw material and consumable suppliers including onboarding and qualification activities.
• Support the supplier change notification process and ensure notifications are assessed for impact based on risk.
• Support Supplier Corrective Action Request (SCAR) process by issuing supplier complaints and drive for resolution and corrective actions.
• Support quality agreement execution including coordination of negotiations with suppliers, customers and or partners, documentation of those quality agreements, and tracking adherence to quality agreement requirements.
• Support raw material qualification program and management of raw materials used in clinical and commercial programs.
• Support the material onboarding process ensuring all relevant GxP regulations, guidelines, and company policies are followed and in compliance.
• Support change controls, corrective and preventative actions (CAPAs), and quality investigations involving raw materials by completing assigned actions.
• Review quality plans.
• Support investigations to provide root cause analysis and ensure effective corrective actions are taken.
• Ensure compliance, and drive improvement plans where needed.
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline.
• 1-3 years of Quality Assurance experience in pharmaceutical / biotech industries.
• Demonstrated understanding of GxP regulations.
• Preferred 1-3 years of experience with change management.