Senior Quality Assurance Specialist
Amsterdam, Netherlands
5 dagen geleden

Senior Quality Assurance Specialist

Technical Operations & Process Sciences Amsterdam, Netherlands

Position at Seagen

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines.

As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells.

Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission.

By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world.

Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary :

The Global Product Disposition Sr. 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 and meet regional requirements
  • Lead or 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 or leading investigations to determine product impact and distribution, and lead quality operations communication to impacted parties
  • Support Quality Agreement negotiations with vendors, partners, or collaborators supplying Comparator, Companion, or Clinical Products to Seattle Genetics
  • Develop knowledge of regulatory requirements in all regions 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
  • Required Qualifications :

  • 5 years professional work experience in regulated industry with Bachelor degree, or 7 years’ experience with Associate degree
  • Preferred Qualifications :

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