Global Quality Operations Manager

Global Quality Amsterdam, Netherlands


Description

Summary: 

The Global Quality Operations (Global Product Disposition) Manager will work with internal and external stakeholders to ensure the overall compliance of all products distributed to all regions. These stakeholders include Quality stakeholders, ensuring compliant product is submitted to regional Quality for regional release as necessary, and business stakeholders, to understand product supply forecasts for all regions, and to provide accurate status information to aid in production and distribution planning.  

Principal Responsibilities: 

  • Ensure overall compliance of Clinical and Commercial products for all regions 
  • Ensure post-release surveillance commitments are met, including participation in product complaint investigations, Biological Product Deviation Reporting, Field Alerts, and Recalls 
  • Ensure label requirements for each country are defined, and meet regional requirements 
  • Works with QP, RP, and Country Affiliates to release product 
  • Support product shipping validation activities 
  • Lead or participate in Material Review Board meetings 
  • Supports Quality Agreement negotiations with vendors, partners, or collaborators supplying Comparator, Companion, or Clinical Products to Seattle Genetics 
  • Stays current on regulatory requirements in all regions where product is actively distributed for both Clinical and Commercial use, as well as potential future markets Influence cross-functional teams to meet compliance and business needs 
  • Assess current business processes for the team, and identify opportunities for continuous improvement to drive efficiency, scalability, and risk reduction 
  • Manages a team of two or more junior Quality professionals  

Required Qualifications: 

  • 8 years professional work experience with Bachelor’s degree 

Preferred Qualifications: 

  • Bachelor’s degree in scientific discipline 
  • 12 years professional experience in Quality role in pharmaceutical or biotech company 
  • 2+ years Managerial experience 

As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seagen, please visit www.Seagen.com. 
 
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.   

 

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