Sr. Specialist QA Systems- Data Integrity

Technical Operations & Process Sciences Bothell, United States


Description

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 Sr. Specialist is a key Quality representative for the implementation of Data integrity and Quality Risk Management programs at the manufacturing site. The Sr. Specialist is responsible for managing the day-to-day activities of the data integrity and risk management programs and proactively identifying and escalating key issues to management.  The Sr. Specialist is responsible for training staff in data integrity and risk management principles; assisting staff with completion of day-to-day assignments / tasks; ensuring compliance with procedures; and implementing program improvements to align with current industry best practices. The incumbent must be able to interact with staff at various management levels and make presentations to internal and external customers on specialized and highly technical aspects of the relevant programs.   

Principal Responsibilities: 

  • Manage quality processes or programs, including:   
    • leading discussions with mid- to senior staff on status of key activities and risks within the program 
    • assisting junior to mid-level staff with performing program assessments and activities 
    • developing new business processes 
    • developing and providing training for the process or program 
    • processing complex records that may involve external parties 
    • developing new metrics, evaluating metrics, and reporting to department management 
  • Lead the successful completion of cross-functional projects 
  • Provide quality site support for the Data Integrity and Risk Management Programs 
  • Ensure compliance with global directives, policies and current industry expectations 
  • Write/revise and collaborate on Quality directives, and approve standard operating procedures that impact multiple departments or programs based on industry best practices; ensure documents reflect current practices 
  • Participate as an SME in audits and inspections, as needed 
  • Represent Quality Systems on cross-functional teams or teams with external parties 
  • Lead continuous improvement activities that may involve a team 
  • Make independent decisions within the areas of expertise, with support from management on more complex issues 
  • Conduct and manage cGMP Risk Assessment/Analysis using various Risk Assessment tools 
  • Coordinates and continuously support the Data Integrity and Quality risk management programs at the site. 
  • Participates in global Data integrity and Risk Management initiatives as a site representative 
  • Train, coach and facilitate risk assessment teams using various risk assessment tools
  • Promote a high commitment to Data Integrity and Risk Management quality and compliance at the site

Required Qualifications: 

  • 10+ years in GMP operations, preferably in the biopharmaceutical or the pharmaceutical industry 
  • Working knowledge of current industry practices and standards 
  • Experience with managing risk related to cGMP Manufacturing and Testing 
  • Experience with managing Data Integrity in Pharmaceutical industry using ALCOA+ principles 
  • Experience in regulatory inspections 
  • Advanced expertise with Office 365, especially Excel 
  • Experience with applicable software (e.g., Learning Management System, electronic Quality Management System, data analytics, etc.) 
  • Excellent written and oral communication skills 
  • Demonstrated problem-solving skills and techniques commensurate with job level 
  • Ability to manage routine and non-routine workload with little-to-no routine oversight 

Preferred Qualifications: 

  • Six-Sigma Certification  

 

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.   

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. 

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