Senior Manager, Quality Validation

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! 

Summary: 

The North Creek Quality Validation Manager is responsible for maintaining and ensuring site compliance to corporate policies and procedures for the validation of GxP laboratory, manufacturing, CSV, and utility systems to comply with 21 CFR Part 11, 58, 210 and 211, Eudralex regulations and ICH guidelines. The manager will lead a team of QA Validation professionals responsible for quality oversight of validation and qualification protocols and reports as they apply to North Creek facilities, utilities, equipment, computer systems, cleaning, and processes. Additionally, the Quality Validation manager will support facility start-up activities, technical transfers, re-qualifications, and routine activities as they pertain to Laboratories, Manufacturing, Facilities, Maintenance and Warehouse functions. 

 
Principal Responsibilities: 

  • Manage site quality validation function responsible for QA oversight of facility, equipment, utility, method, computerized systems and process validation  
  • Ensure site compliance with policies, procedures, and tools to ensure GxP systems are validated and controlled to comply with US and EU GMP regulations and ICH guidelines 
  • Ensure application of the site validation master plan  
  • Provide QA oversight in the development, review and execution of protocols, reports, risk assessments and deviations 
  • Perform change control assessment and approval to assure proper impact assessment and sufficient testing to develop and maintain a validated state 
  • Participate in cross-site alignment and community of practice for equipment, system qualification discipline 
  • Provide guidance and act as Quality point of contact for the validation of laboratory, manufacturing, CSV, and utility systems at the Seagen North Creek site 
  • Manage group projects and workload to support the validation lifecycle of site equipment, facilities, utilities, systems, and process
  • Responsible for managing QA oversight of the equipment management program at the North Creek site to include equipment onboarding and calibration/maintenance programs 
  • Develop personal and team goals, partner with other departments for goals and plans 
  • Develop, mentor, and train staff 
  • Lead / facilitate the development of sound risk-based test strategies and plans 
  • Gather and evaluate data for trending and monitoring of the validation process 
  • Drives continuous improvement by monitoring metrics and implementing lessons learned 
  • Provide validation support for audits and inspections, as needed 
  • Support audits of system suppliers, acting as a QA validation SME 
  • Provide quality support for complicated and or novel validation efforts, as required 

Required Qualifications: 

  • 2+ years prior management experience 
  • 12+ years relevant GMP and/or validation experience 
  • Strong working knowledge of system validation following industry standards (GAMP and ISPE), and cGMP is required, including ability to interpret and apply industry specific guidance's 
  • Working knowledge of process validation, process characterization, technology transfer and continued process verification 
  • Previous experience working with change management systems 
  • Excellent written and verbal communication skills 
  • Ability to proactively identify and implement continuous improvements 
  • Proven ability to work effectively in a fast-paced team environment 
  • Ability to organize information in a consistent and readily retrievable manner 

Preferred Qualifications: 

  • Prior QA facility experience 
  • Previous audit experience 
  • Involvement with industry groups such as PDA and/or ISPE 

 

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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