Sr. Specialist Global Large Molecule Quality Transfer (Hybrid)

Job Description

As part of the Global Quality Excellence Team our goal is to deliver site-to-site transfers within Large Molecules on time and within budget to ensure compliant and unconstraint supply of Animal Health vaccines supporting growth of the business.

The Large Molecule Transfer Quality team has the end-to-end responsibility to provide Quality Strategy and Direction, Quality oversight and Quality Support to manufacturing sites and transfer leads as well as portfolio management and governance for all site-to-site transfer activities within the Large Molecule regions. We ensure a standardized approach for the execution of process and test transfers and a close collaboration with our quality organizations at the manufacturing sites and global functions across regions​. Our team ensures alignment of transfer activities with the Company's strategy by close collaboration with the Network & Strategy Development Office. The role will be based on one of our manufacturing sites in the US to support site-to-site transfers within the US Region.

• With respect to Transfer Quality Compliance Support, the position ensures appropriate design, implementation and maintanence of GMP and Animal Health Quality Standards during transfers:

  • Development and roll-out of Animal Health Quality Manual documents for Quality Transfer related activities

  • Sharing Best Practices of Quality Transfers across impacted Donor and Receiving Large Molecule sites

  • Support of post transfer activities related to implementation to the sites

• With respect to Transfer Quality Operational Support the position ensures support to the sites on Quality activities implementation, mainly, but not limited to:

  • End-to-End oversight of Quality Control test transfer execution and all related transfer activities (Products, Raw materials, Seed Materials, Biomaterials System, storage, qualification, monitoring, stocks, certification documents, specifications …

To fulfill the role the position will:

• Coach and upskill cross functional team members on Quality aspects of transfers, support and ensure collaboration and exchange of best practices across the network

• Build and maintain a strong relationship with relevant stakeholder groups within Quality, Operations and global functions, coordinating and aligning individual Quality activities across the network

• Partner closely with Donor and Receiving LM Sites to ensure Quality activities deployment

• Partner closely with Large Molecule Animal Health Transfer Task Force Team to ensure consistency between Operations and Quality

• Partner with Global Regulatory Affairs to align on requirements and optimization of documentation, if needed

• Partner with other global support functions such as Global Supply chain, BATS, R&D, APS and others, as appropriate

Location, Travel

• The position is based at an …