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!
We are seeking a highly motivated and experienced international team leader to join us as a Research and Development Quality (RDQ) Director to support our international clinical development programs. This position will be in Bothell, WA, or South San Francisco (or potentially remote) and will report to the Sr. Director, GCP/GLP QA. This role will support international clinical trials through quality oversight, program/study team consultation, and risk assessment. This role will help transform RDQ’s approach to GCP quality assurance (QA) support and risk management. Your advanced, international GCP expertise and management experience will be employed to develop, execute, and optimize cost effective, risk-based, quality assurance and compliance programs. You will manage an international team of QA professionals.
- Leads and manages a group of clinical QA Managers/Senior Managers Directors/Associate supporting GCP
- Drive the execution of a scalable, cost effective, and risk-based quality assurance and compliance infrastructure
- Support R&D Quality Risk Management including such activities as GCP quality advising, risk identification, and CAPA management
- Identify controlled document improvements, creation and training needs within the GCP space
- Works with other leaders within their functions to develop the talent of the future
- Works across all levels in the organization to deliver GCP Quality
- Contribute and implement GCP compliance risk-based audit strategies
- Works cross functionally to solve problems and produce solutions that work for the broader group
- Plan/strategize inspection readiness activities to support program/study team
- Participate in regulatory agency inspections
- Sets objectives for team and direct reports, builds team capabilities, and promotes career development
- Partners with external collaborators, contractors, and contract research organizations to fully support drug development activities
- Minimum of 10 years in pharmaceutical industry
- Minimum 8 years in Good Clinical Practice (GCP) compliance and audit program management
- Minimum of 10 years supervisory/management or project/team management experience
- Advanced knowledge of international GCP regulatory requirements and guidance and have the background and skillset to implement current industry best practices and processes
- Recognized as an expert resource on a range of complex clinical compliance topics including management of potential serious breaches and CAPAs/deviations
- Applies GCP knowledge to perform complex work, demonstrate influence beyond the RDQ function and make decisions on highly complex issues
- Experience preparing and managing global regulatory authority inspections of clinical investigator sites
- Successfully completing global process improvement initiatives
- Proven management skills with ability to lead and mentor others effectively and experience in advocating for a quality environment
- Experience with audit management/CAPA management programs required
- Strong verbal and written communication skills and interpersonal skills
- Excellent organization and project management skills
- Bachelor’s degree or equivalent
- Up to 25% travel
- Oncology Therapeutic area expertise or technical expertise to support clinical drug development
- International Team Leadership with focus on implementing current industry best practices
- Quality Assurance Audit or Audit Program Management Qualification/Certification
- Experience in implementing Organizational Change Management and Risk Management tools and governance
- Master’s Degree
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.
The hiring pay range for this position is $186,000 to $241,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.
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.