Manager Global Product Disposition

Global Quality Bothell, Washington


Description

Summary:

The 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
  • Support product shipping validation activities
  • Lead or participate in Material Review Board meetings
  • May lead 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
  • May manage others

 

Required Qualifications:

  • 12 years professional work experience with Bachelor’s degree; in lieu of BS degree equivalent direct experience of four years working in GMP environment
  • 2+ years Managerial experience

 

Preferred Qualifications:

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

 

As the leading employer in our industry in the Pacific Northwest, 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. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com. 

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.