Associate Director Quality Management Systems - Launch Pad

Technical Operations & Process Sciences Bothell, United States


Description

Position at Seagen

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: 

The Associate Director of Site Quality Management Systems is responsible for managing all activities related to the development and implementation of the site Quality Management Systems (QMS) at our new manufacturing site (Drug Substance, Drug Product, Testing, Labeling and Packaging) in Everett, WA.  

Responsibilities include authoring and approving site-specific SOPs; collaborating on corporate program for Launch Pad site-specific needs; participating in relevant Communities of Practice; providing site customer support; and owning and generating site QMS metrics for tracking and trending. This position will also coordinate and conduct the Site Management Review and report key quality and performance indicators to the site management as required, and foster continuous improvement efforts to assure compliance, and alignment with business needs and current industry best practices. The position will also assist in support of the site during audits (regulatory, partner, internal). The position must be able to interact with staff at various management levels and make presentations to internal and other customers. People management responsibility is required. 

This position reports to the Launch Pad Site Quality Head. 

Principal Responsibilities: 

  • Lead and manage Launch Pad day-to-day site activities and cross functional projects to support QMS programs (Deviation, CAPA, Change Control) 
  • Manage Document Control and GMP Document Lifecycle 
  • Lead, coordinate, and conduct site management (metrics) review forum  
  • Lead, coordinate, and conduct site QMS review forum/boards (Deviations, CAPA, Change Control)  
  • Report on internal site and key quality and performance indicators as requested  
  • Represent Launch Pad Site Quality on Corporate cross-functional teams participating in various operational programs and other continuous improvement activities 
  • Develop, implement, and manage staff and workload, ensuring that staff are appropriately trained to perform job function 
  • Attend and participate in community of practice (COP) for QMS as site quality representative 
  • Write/revise site specific SOPs; and collaborate on corporate programs (Directives) for site-specific needs and reflective of current practices 
  • Guide the successful completion of site projects and may function in a project leadership role 
  • Develop and maintain relationships with cross-functional Seagen staff to support site QMS activities 
  • Make independent decisions within the defined procedures and practices of the QMS programs, with oversight from site management on more complex issues 
  • Provide SME support for audits and inspections, such as providing site records and data from the QMS upon request 
  • Interpret complex QMS metrics and evaluate trend data; report out to Launch Pad site leadership and cross-functional management at specified intervals 
  • Lead discussions with mid to senior level staff on status of key activities, programs, and escalation of any identified risk 
  • Manage a portfolio or suite of interrelated continuous improvement projects 
  • Manage eQMS records to ensure compliance with document control procedure and work with staff for necessary corrections 
  • Determine how to execute projects and goals set by senior leaders. Interactions are largely, but not only, with internal customers and various management levels, occasionally with executives 
  • Develop technical expert skills in QMS to be able to analyze complex workflow/system issues and provide solutions. 

Expected Qualifications: 

  • Bachelor’s degree in life science in biology, biochemistry, or any related technical discipline 
  • A minimum of 10 years relevant experience in a regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required (recommended 16+ years overall relevant experience) 
  • A minimum of 5 years in direct supervision of staff 
  • Minimum 4 years of primary experience in QMS (deviation, CAPA, change control), such as overseeing QMS programs and Document Control 
  • Strong technical skillset supporting work within various electronic systems including the electronic Quality Management System, Microsoft Office, and data analytics tools 
  • Strong working knowledge of cGMP, including ability to interpret and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance 
  • Excellent written and oral communication skills 
  • Proven ability to work effectively in a fast-paced team environment 
  • Ability to organize information in a consistent and readily retrievable manner 
  • Strong leader and team player that can also work independently to achieve objectives 

Preferred Qualifications: 

  • Experience with clinical and commercial pharmaceutical/biopharmaceutical products. 
  • Ability to communicate to drive action and inform of project status 
  • Ability to lead meetings and to provide and report metrics 
  • Experienced with various electronic quality management systems 
  • Strong experience with MS-Word, Excel, Project, PowerPoint, SharePoint, OneNote, and Visio 
  • Excellent technical writing, communication, and analytical skills 

 

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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