Senior Manager GLP Compliance

Regulatory Affairs Bothell, Washington


Description

Summary: 

 

This position reports to the Director of GLP Compliance, R&D Quality and is responsible for the management and conduct internal and external, domestic and international GLP audits and some GCP audits, in accordance with applicable government regulations, FDA- GLP, ICH-GCP, and Seagen SOPs. The Senior Manager, GLP Compliance will ensure audits are conducted and reported in a timely manner and in accordance with an audit plan. Additionally, the Senior Manager, GLP Compliance is responsible for supporting GLP inspection and some GCP inspection activities. 
 
Responsibilities: 

 Provide GLP Compliance support by: 

  • Assigning staff to participate in study team meetings 
  • Providing compliance advice to Bioanalytical Testing, Nonclinical Science and Clinical 
Operations (teams) 
  • Approving audit plans developed by audit staff 
  • Overseeing work performed by staff and any contract auditors
Develop an annual audit schedule to include audits of: 
  • GLP Laboratories 
  •  Internal processes 
  • Some Clinical Service Providers 
  • Documents for regulatory submissions 
  • Review audit reports 
  • Trend audit issues 
  • Report significant and/or serious compliance issues to Senior Management 
  • Develop, review, revise and/or implement Quality SOPs, tools and templates and collaborate when requested on Clinical Operations SOPs 
  • Facilitate regulatory inspections 
  • Participate in Quality Management System improvement initiatives 
  • Manage GLP archives and archivist 
  • Other assignments as required 
     

Skills and Knowledge: 

  • Current knowledge of Code of Federal Regulations and ICH Guidelines governing clinical/non-clinical studies and recent initiatives 
  • Knowledge of auditing techniques 
  • GLP auditing experience (some GCP auditing experience) 
  • Familiarity with pharmacovigilance processes 
  • Experience with auditing oncology studies 
  • Future oriented, sets clear objectives and monitors progress 

Minimum Qualification(s): 

  • Bachelor’s degree, Master’s Degree (preferred), 7+ years’ experience in GLP auditing of clinical and non-clinical sites and service providers 
  • Drug development experience (12+ years with 5+ years supervisory experience) 
  • Up to 30% travel 
     

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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