Seagen

Director, Country Quality, International

Description

Founded in 1998, Seagen is a global biotechnology company and the largest based in the Pacific Northwest in the U.S. The company discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people’s lives. The company is headquartered in the Seattle, Washington area, with locations in California, Switzerland and the European Union. Seagen is publicly traded on the Nasdaq Stock Market under the symbol SGEN and employs over 1,850+ employees worldwide.

ADCETRIS® (brentuximab vedotin) and PADCEV® (enfortumab vedotin-ejfv) use the company’s industry-leading antibody-drug conjugate (ADC) technology. ADCETRIS is approved in certain CD30-expressing lymphomas, and PADCEV is approved in certain metastatic urothelial cancers. TUKYSA® (tucatinib), a small molecule tyrosine kinase inhibitor, is approved in certain HER2-positive metastatic breast cancers. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors. More information about Seagen can be found at www.seagen.com

Position Summary:

The Director of Country Quality is responsible for all quality aspects associated with the global expansion of Seagen’s commercial operations with focus in Europe and Canada. You will be responsible for establishing and developing Quality personnel and systems across Seagen affiliates globally, and establish the oversight of distribution activities in all regions to support new product launches and ongoing commercial supply in these countries.

Principal Responsibilities:

• Responsible for quality in the countries and affiliates
• Assure internal and external stakeholders (General Manager, Local/Regional Health authorities, etc.) that Quality and GDP requirements are continuously met in the areas of highest impact: Patient protection as well as reliability of our distribution processes of therapies to patients
• Implement and monitor all Quality Management Systems to ensure compliance in each country with QMS requirements and Regional/National directives
• Create and implement best practice across the region, drive the regional quality vision, strategy, policies, processes and procedures in alignment with Seagen global quality roadmap
• Drive continuous improvement activities across the region to ensure problems are prevented and issues are resolved efficiently and economically
• Provide quality leadership to local Quality Representative (QP, Responsible Person/Pharmacists) in the region and coach them to deliver the global and local quality strategy so that Seagen Quality requirements are embedded in all affiliate activities
• Lead the local affiliate quality representative in the region to provide quality oversight of all local distribution and warehousing activities and ensure compliance to GDP requirements and Seagen Quality policies, and if/when needed drive improvement actions with local affiliate management
• Ensure adequate execution of core quality activities: CAPA, management review, complaint, internal audit, GDP training, change control, documentation control, oversight of warehousing and distribution in each affiliate
• Ensure local affiliate quality representative manage and investigate incidents (i.e. Product Complaints, Distribution Deviations etc.) through the appropriate Quality Management Systems
• Lead the management of regulatory inspections and audits at the affiliate in coordination with the local affiliate quality representative
• As part of the Management Review process, the Quality Director of Country Quality will provide periodic update to the Local Affiliate Management and drive decisions for improvement actions as needed
• In collaboration with the Corporate Quality organization, weigh and communicate quality and compliance risks as appropriate
• Act as a Quality liaison between the local affiliates and Corporate Quality for GMP/GDP functions and activities
• Partner with local, regional and global operation groups to foster a proactive approach to compliance
• Ensure that Quality meets or improves on budget, cost, efficiency targets (KPIs) in line with business objectives
• Develop the technical, GMP and leadership skills of direct reports, including performance reviews

Required Qualifications:

• 15+ years of experience working in biopharmaceutical industry, with specific focus on Country Quality operations, Qualified Person status, and/or Quality Compliance at a country/affiliate
• Demonstrated ability to influence executive leadership on complex technical and quality related topics with attention to detail and desire to achieve team and individual goals
• Excellent verbal and written communication skills (technical reports, professional reports, presentation, and emails)
• Sound knowledge and working experience of EU regulatory requirements for warehousing and distribution of medicines (EU GMP Annexe 16, Annexe 21)

Preferred Qualifications:

• Bachelor’s degree or equivalent in scientific, quality-related field, biology, chemistry, or pharmaceutical studies, or equivalent combination of education, training and experience
• Prior Experience in Country Quality Assurance, or managing Quality Systems and/or Compliance in a country/affiliate is a plus
• Working knowledge and experience managing distribution networks and affiliates in Asia and/or Latin America would be an asset
• Strong project management skills and experience managing multiple projects at the same time is essential
• Proven track record in providing compelling visions to remote employees and coaching networks of remote collaborators
• Fluent in written and spoken English

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 12/04/2020