GCLP Biomarker and Laboratory Compliance Manager

Regulatory Affairs Bothell, Washington US Field Based


Description

Summary: 

We are seeking a highly motivated individual to join us as a Good Clinical Laboratory Compliance (GCLP) Manager to support our drug development programs.  This position will be in Bothell, WA, or South San Francisco, CA (or potentially remote for the appropriate candidate) and will report to the GCP Director.  This role will support international clinical trials through quality oversight, program and laboratory team consultation, and auditing.  Your GCLP technical expertise will be employed to develop and implement a cost effective, risk-based, quality assurance and compliance programs with a strong focus on the Biomarker development space. 

Responsibilities: 

  • Performing as a lead auditor for GCLP, GCP, and/or GLP audits 
  • Interpreting and assessing the nuances of research and regulations that fall in between GLP and GCP 
  • Understanding of sample management, method validation, and analytical methods 
  • 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 

Qualifications: 

  • Minimum 5 years in Good Clinical Laboratory Practice (GCLP), Good Clinical Practice (GCP), and/or Good Laboratory Practice (GLP) Auditing 
  • Minimum 7 years in pharmaceutical industry 
  • Internal/Contract laboratory auditing 
  • Experience supporting regulatory authority inspections of clinical research or laboratories 
  • Participation in process improvement initiatives 
  • Intermediate leadership or mentoring experience 
  • BS/BA degree in Biology, Biochemistry, Immunology, Analytical Chemistry, or other related scientific discipline 

Preferred Qualifications: 

  • Oncology Therapeutic area expertise or technical expertise to assess laboratory activities for clinical drug development 
  • An understanding of translational approaches as applied to clinical trial design and regulatory processes, proof-of-concept studies, and the implementation of biomarkers and diagnostics 
  • Experience with the development and validation of protein- and/or nucleic acid-based assays such as Flow Cytometry, Immunohistochemistry, PCR, genomic profiling, or gene expression analysis 
  • Familiarity with various lab equipment 
  • Working knowledge of CAP/CLIA/NYS and/or international laboratory regulations 
  • 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. 

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