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!

Summary:

We are seeking a highly motivated and experienced international team leader to join us as a Research and Development Quality (RDQ) Sr. Director to support our international nonclinical and clinical development programs. This position will be in Bothell, WA, or South San Francisco (or potentially remote) and will report to the Executive Director, RDQ. This role will support international nonclinical and clinical trials through quality oversight, program team consultation, risk assessment, and audit program management. This role will help transform RDQ’s approach to GLP and GCP quality assurance (QA) support and auditing methods. Your advanced, international GCP and GLP 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 managerial staff.

Principal Responsibilities:

• Leads and manages a group of non-clinical and clinical QA Directors/Associate Directors supporting GCP and GLP. May have several areas reporting into them such as GCP QA molecule (product) support, GLP Quality Assurance Unit, and the GxP QA auditing function. Determines resourcing and budgeting needs for assigned areas
• Acts as a member of the RDQ leadership team responsible for setting the long-range plans and the RDQ GLP and GCP Global Strategy in concert with the Head of RDQ
• Identify keys areas of improvement within the GCP and GLP space and have experience identifying training needs and controlled document improvements and creation
• Works with other leaders within their function to develop the talent of the future
• Manages across all levels in the organization as the voice of GLP and GCP Quality. Interfaces with governing committees and EC leaders to help influence the Seagen Quality Culture
• Plays a key role in the Development Governance Structure (e.g., Quality Council, Quality Forum, Development Metrics Review). Presents metrics, trends, and emerging topics to decision making bodies. Gains alignment on decisions and goals
• Works cross functionally to solve problems and produce solutions that work for the broader group
• Hosting regulatory agency inspections and supporting the Inspection Management team

Required Qualifications:

• Minimum of 15 years in pharmaceutical industry
• Minimum 10 years in Good Clinical Practice (GCP) and/or Good Laboratory Practice (GLP) audit program management
• Minimum of 10 years supervisory/management or project/team management experience
• Well versed in international GLP and GCP regulatory requirements and guidance and have the background and skillset to implement current industry best practices and processes
• Experience preparing for and hosting global regulatory authority inspections of clinical research
• Successfully completing global process improvement initiatives
• Management of compliance staff and experience in implementing clinical trial oversight and auditor competency programs
• International QA leadership experience
• Bachelor’s degree or equivalent
• Up to 25% travel

Preferred Qualifications:

• Good Vigilance Practice QA experience
• 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.

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.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

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