Senior Manager Site Quality Operations - 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! 

Summary:  

The Sr. Manager of Quality Assurance Operations is responsible for managing the QA team that provides and assures quality and compliance for activities related to the manufacturing and testing operations at our new manufacturing site (Drug Substance, Drug Product, Testing, Labeling and Packaging) in Everett, WA.  

Responsibilities include developing a quality operations team that will provide quality oversight for the Launch pad facility. This includes the review and approval of GMP documents and quality records related to manufacturing and testing of clinical and commercial products. Additionally, the Senior Manager of Quality Assurance Operations will oversee the QA on the floor support that provides guidance and assurance to the manufacturing team during operations. The position will also assist in support of the site during audits (regulatory, partner, internal), alignment with quality operation at other Seagen sites and serve as the site SME for QA operations. 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 Director of Quality Assurance Operations. 

Responsibilities:  

  • Provide quality oversight of manufacturing and testing of bulk drug substance and drug product products to ensure the GMP compliance of operations performed at Launch Pad 
  • Manage QA team to perform review and approval of batch documentation including manufacturing records, analytical data, and deviations in preparation for lot disposition 
  • Manges In-plant Quality Assurance with on-the-floor Quality oversight during drug substance and drug product operations, including filling operations, aseptic processing simulations, visual inspections, AQLs, labeling and packaging 
  • Develop, implement, and manage resources and workload, ensuring that staff are appropriately trained to perform job responsibilities 
  • Reviews and approves quality records that support GMP operations for manufacturing and testing including SOPs, deviations/CAPAs, change records, stability protocols, OOS/OOT investigations, laboratory investigations, manufacturing batch records, product specifications 
  • Subject matter expert for QA operations supporting operational excellence initiatives for manufacturing and testing processes  
  • Report significant and/or serious compliance issues to site leadership and participate in required corrective action planning as needed 
  • Evaluate and approve proposed manufacturing and testing process changes 
  • Participate in GMP internal and regulatory inspections of the Launch Pad facility 
  • QA Lead for program technology transfers, New Product Introductions and Process Performance Qualifications 
  • Drives alignment with other Seagen QA operations at manufacturing sites to foster strong communication, shared issues, and improvements among the sites 
  • Develop, mentor and train staff 

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  
  • Minimum of 3+ years of managing staff  
  • Strong knowledge of cGMP and applicable FDA/international regulations 
  • Direct experience with plant operations, pharmaceutical/biotechnology manufacturing, and analytical testing 
  • Demonstrated ability to lead, develop and build a Quality team 
  • Demonstrated ability to work cross-functionally and develop and maintain collaborative business relationships  
  • Excellent communication skills with internal and external personnel essential 
  • Experience with electronic documentation management, deviation/CAPA management and change control management systems 
  • Demonstrated commitment to a culture of continuous improvement 
  • Ability to anticipate and mitigate challenges 
  • Experience working with clinical products and supporting internal, partner and/or regulatory inspections 

Preferred Qualifications:  

  • Drug product manufacturing and operations experience in a cGMP environment 
  • Commercial experience in a regulated biotechnology, pharmaceutical company 
  • 5+ years of managing staff 
  • Master’s degree in life science or any related technical discipline 

 

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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