Manager GCP Quality Assurance

Development 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: 

We are seeking a highly motivated individual to join Research and Development Quality (RDQ) as a Manager, GCP Quality Assurance, to support our drug development programs.  This position will be based as a hybrid employee in Bothell, WA, or South San Francisco, CA. Remote candidates will be considered but would need to be US based. The Manager, GCP Quality Assurance will report to the GCP Associate Director. This role will support international clinical trials through quality oversight, program and team consultation, and auditing. Your Good Clinical Practice (GCP) technical expertise will be employed to develop and implement cost effective, risk-based, quality assurance and compliance programs.       

Principal Responsibilities: 

  • Performing as a lead auditor for GCP audits 
  • Leading Directed audits 
  • Advising program teams independently for routine compliance inquiries  
  • Designing and managing compliance programs for assigned programs 
  • Managing regulatory agency inspections 
  • Communicating results of compliance programs to development teams 
  • Conducting risk assessments for assigned area 
  • Supporting achievement of departmental goals 

Required Qualifications: 

  • Minimum 5 years in Good Clinical Practice (GCP) 
  • Minimum 7 years in pharmaceutical industry 
  • Clinical Site and Internal/Contract Research Organization auditing 
  • Experience supporting regulatory authority inspections 
  • Participation in process improvement initiatives 
  • Intermediate leadership or mentoring experience  
  • BS/BA degree or equivalent 

 Preferred Qualifications: 

  • Oncology Therapeutic area expertise or technical expertise to assess activities for clinical drug development 
  • International auditing experience 
  • Compliance program or project management 
  • Quality Assurance Qualification/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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