Quality Third Party Management Specialist

Role Summary

Quality Third Party Management Specialist at Framingham, MA. Oversees Third Party Quality for the MA BioCampus, ensuring high-quality standards and regulatory compliance in relationships with external partners. Key responsibilities include leading SCN management, TPE management, quality agreement programs, and maintaining regulatory awareness.

Responsibilities

• Lead the Supplier Change Notification (SCN) process
• Provide training on SCN workflow
• Ensure cross-functional approach to SCN completion
• Coordinate subject matter expert involvement
• Maintain system health and timely responses

• Collaborate with third parties on investigations
• Ensure cross-functional approach to TPE completion
• Manage returns of investigation materials to third parties

• Support Sanofi MA sites and Global quality agreements
• Develop and maintain periodic review schedules
• Assign and oversee quality agreement reviews
• Ensure all quality agreements are approved and properly documented

• Interpret complex documentation for new and current compliance procedures
• Stay informed on regulatory enforcement trends and actions

• Assist in resolving compliance issues related to third parties
• Collaborate with Manufacturing, Continuous Improvement, Operational Excellence, Quality Assurance, Quality Control, Facilities, and other departments

Qualifications

• Required: Bachelor‚Äôs degree with 6+ years in Quality and/or Operations experience in a biotech/pharmaceutical cGMP
• Required: Manufacturing environment within a FDA-regulated industry

• Preferred: Proficient in Veeva quality management system
• Preferred: Experience in third-party quality investigations, quality agreements, and supplier change notifications
• Preferred: Skill in analyzing complex documentation for regulatory compliance
• Preferred: Knowledge of global pharmaceutical regulations (US, EU, Canada, Japan, Australia)
• Preferred: Excellent communication and presentation skills with ability to influence senior management; experience in LEAN and continuous improvement
• Preferred: Ability to identify trends and develop key performance metrics

Skills

• Analytical thinking
• Strong communication abilities
• Quality management systems in pharmaceutical industry

Education

• Bachelor‚Äôs degree (required)

Additional Requirements

• Ability to gown and gain entry to manufacturing and warehouse areas