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Seagen
Clinical Compliance Manager
Regulatory Affairs - Bothell, Washington - US Field Based - Seattle, Washington - South San Francisco, California
Description
Summary
We are seeking a highly motivated individual to join us as a Clinical Compliance Manager to support our drug development programs. This position will be ideally based in Bothell, WA, or South San Francisco, CA and will report to the GCP Director. This role will support international clinical trials through quality oversight, program, and team consultation, and auditing. Your Good Clinical Practice (GCP) technical expertise will be employed to develop and execution of cost effective, risk-based, quality assurance and compliance programs.
Principal Responsibilities:
- Performing as a lead auditor for GCP audits
- 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
Required Qualifications:
- Minimum 5 years in Good Clinical Practice (GCP) required
- Minimum 7 years in pharmaceutical industry required
- Internal/Contract Research Organization auditing
- Experience supporting regulatory authority inspections
- Participation in process improvement initiatives
- Intermediate leadership or mentoring experience
- BS/BA degree or equivalent
Preferred Qualifications:
- Oncology Therapeutic area expertise or technical expertise to assess activities for clinical drug development
- 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.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 01/29/2021
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