Quality Operations Specialist

Global Quality Amsterdam, Netherlands


Description

Summary: 

The Global Product Disposition Specialist 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 
  • Support product launch activities for introduction of product into new countries 
  • Assure compliance of products released to distribution and market, including Regulatory compliance check to Product Specification File, Filings, etc. 
  • Assure compliance of products released for use in Investigator Sponsored Trials and Patient Access Programs 
  • Participate in Regulatory inspections 
  • Ensure label requirements for each country are defined 
  • Participate in Material Review Board meetings as needed 
  • Provide administrative support for Material Review Board meetings, such as schedule and facilitate meetings, scribe, and distribute meeting minutes, and draft executive summaries 
  • Participate in investigations to support timely regulatory actions and communication when warranted 
  • Support Product Recall team, participating in investigations to determine product impact and distribution, and lead for quality operations communication to impacted parties 
  • Support Quality Agreement negotiations with vendors or partners to Seattle Genetics 
  • Develop knowledge on regulatory requirements in United States and Canada, where product is actively distributed for both Clinical and Commercial use, as well as potential future markets 
  • Assess current business processes for the team, and identify opportunities for continuous improvement to drive efficiency, scalability, and risk reduction 
  • Influence cross-functional teams to meet compliance and business needs 

Required Qualifications: 

  • 3 years professional work experience in regulated industry with Bachelor's degree 

Preferred Qualifications: 

  • Bachelor’s degree in scientific discipline 
  • 8 years professional experience in Quality role in pharmaceutical or biotech company 

 

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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