Senior Supplier Quality Specialist

Responsibilities

• Responsible for maintaining Lantheus’s Supplier Quality Management (SQM) program.
• Ensure that systems, processes and procedures between Quality, Supply Chain, Technical Operations and R&D are compliant and aligned with business needs.
• Act as the primary point of contact and relationship manager for Third Party Logistics (3PL) and Pharma Partners.
• Develop and manage an Approved Vendor List and procedures for supplier lifecycle management.
• Oversee supplier performance on an ongoing basis and implement a program of monitoring and continuous improvement.
• Execute all actions that contribute to the success of maintaining a compliant vendor management program.
• Maintain oversight and execution of all assigned Corrective and Preventative actions related to Supplier Quality management.

• Requires a BS degree in a scientific discipline and minimum of 7+ years’ experience in a GMP environment, preferably in a Quality-related discipline or Supplier Quality Management within the Pharmaceutical, Biotech and/or Medical Device industry, or equivalent combination of education and experience.
• Incumbent must have excellent written, verbal and presentation skills.
• Must be able to interact effectively with all levels of management, both internal and external.
• Must have a good understanding of cGMP requirements by FDA, EMA, ICH Q8, 9 and 10.
• Must have demonstrated experience with Quality Management System databases.
• Requires the ability to work independently to own projects and execute to 100% completion with minimal supervision.
• Strong negotiating and collaboration skills are essential; incumbent must be able to influence and drive suppliers to high levels of performance.
• Travel to suppliers (about 25%) will be required based on business needs.
• Strong understanding of principles of Analytical/Chemistry required to support Supplier Analytical Testing and method development preferred but not required.

Demonstrates expertise in Supplier Quality Management and compliance with cGMP requirements, ensuring effective vendor management and continuous improvement in supplier performance. Strong communication and negotiation skills facilitate collaboration across Quality, Supply Chain, and Technical Operations.

• Supplier Lifecycle Management
• Corrective and Preventative Actions
• Performance Monitoring Analytical Testing
• Method Development

• Excellent Written Communication
• Verbal Communication
• Presentation Skills
• Negotiation Skills
• Collaboration Skills

• Pharmaceutical Industry
• Biotech Industry
• Medical Device Industry
• FDA Regulations
• EMA Regulations
• ICH Q8
• ICH Q9
• ICH Q10
• GMP Environment