Seagen
Specialist Quality Operations
Technical Operations & Process Sciences - Bothell, United States
Description
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 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.
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
Qualifications:
- Eight years professional work experience in regulated industry with Bachelor's degree, or 10 years' experience with Associate’s degree
Preferred Qualifications:
- Bachelor’s degree in scientific discipline
- 8 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, visit www.seagen.com.
The hiring pay range for this position is $98,000 to $126,500 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.
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.
To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 06/24/2022
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