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Senior Manager, GCP Compliance

Employer
Seagen
Location
Zug, Canton of Zug (CH)
Salary
Competitive pay, 401k, Medical/Dental/Vision benefits
Closing date
Jul 30, 2022
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Job Details

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 visitwww.Seagen.com. 
 

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

Company

Seagen is a global biotechnology company that develops and commercializes transformative cancer therapies. We’re driven by a singular mission—to make a difference for people impacted by cancer.

As an industry leader in antibody–drug conjugate (ADC) technology, we pioneered the science of harnessing antibodies designed to deliver cell-killing agents to cancer cells. Three of our four approved medicines are built on this technology.

We also focus our research efforts on novel targeted small molecule therapies. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents.

Find Us
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