Senior Manager, GCP Compliance

Development Zug, Switzerland


Description

Position at Seagen

Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information about Seagen can be found at www.Seagen.com

Position Summary

We are seeking a highly motivated team leader to join us as a Senior Manager, Clinical Compliance to support our drug development programs.  This position will be in Zug, Switzerland, or potentially remote and will report to the Associate Director, GCP.  This role will support international clinical trials through quality oversight, program team consultation, and auditing.  The incumbent’s advanced GCP expertise will be employed to develop and execute cost effective, risk-based, quality assurance and compliance programs. 

Principal Responsibilities

  • Advise program teams independently for intermediate compliance inquiries
  • Manage resources according to RDQ strategic audit plan internationally
  • Define Directed Audit Plans and/or leading Directed Audits
  • Ensure audits/assessments are conducted and reported to established regulatory and Seagen standards
  • Implement departmental goals, infrastructure and procedures
  • Ensure consistency with RDQ processes and procedures
  • Foster collaboration across RDQ functional teams
  • Identify and raising major risks/areas of exposure to senior management
  • Manage the preparation activities for regulatory authority inspections
  • Oversee expense reports

Qualifications

  • Minimum 5 years in Good Clinical Practice (GCP) Auditing
  • Minimum 7 years in pharmaceutical industry
  • Supervisory/management experience (1-2 years)
  • Experience managing regulatory authority inspections of clinical research
  • Project or team management experience
  • Leading process improvement initiatives
  • BS/BA degree or equivalent
  • ability to travel up to 40%
  • thorough understanding of local compliance, as well as a sound ethical approach to business

Preferred Qualifications

  • Oncology Therapeutic area expertise or technical expertise to support clinical drug development
  • International auditing experience
  • Clinical Quality Assurance Qualification/Certification

As a leading employer in our industry, 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. To learn more about Seagen, please visit www.Seagen.com. 
 

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.   

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