Seagen

Senior Manager, GCP Compliance

Development - Zug, Switzerland

Description

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!

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 I
• mplement 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 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

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/04/2022