Senior Manager/Associate Director, Supply Chain Quality

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. QA Manager, Supply Chain Quality leads a team responsible for quality oversight of shipping, receiving, materials storage and materials management operations.  The Sr. Manager of Supply Chain Quality is accountable for the development and performance of the Supply Chain Quality team.  The Sr. Manager will act as the single point of contact and subject matter expert with the Global Logistics team for transportation of clinical and commercial products across manufacturing stages, up to the final distribution service providers. In addition, the Sr. QA Manager will ensure quality oversight of clinical distribution shipping events, including temperature excursions. This position drives and oversees improvement of supply chain quality processes and systems and partners with cross functional leaders to develop programs and strategies to ensure a safe and high-quality supply chain.  
 
Principal Responsibilities: 

  • Manage a team responsible for quality oversight of the transportation of Seagen clinical and commercial products across the manufacturing stages, up to the final distribution service providers 
  • Partner with Global logistics to ensure safe transport of temperature-sensitive goods and products through the supply chain
  • Ensure that the quality and integrity of medicines is maintained within the legal supply chain during storage and/or transportation 
  • Act as a designated representative/responsible person for state pharmaceutical license renewals in the US; including approval of license renewal applications
  • Ensure logistics providers are qualified and negotiate Quality Agreements 
  • Monitor, report, and manage logistic provider quality performance  
  • Ensure quality review and approval of routine shipping requests 
  • Oversee management of temperature excursions and deviations that occur during shipment 
  • Ensure quality oversight of shipping validation and qualification of commercial transportation lanes
  • Provide quality oversight of clinical distribution shipping  
  • Monitor, evaluate and report quality metrics  
  • Manage personnel responsible for quality support of internal warehousing operation 
  • Lead hiring, mentoring and staff development 
  • Participate in development of strategy and goals for staff 
  • Complete all job-related training while striving to continuously improve on knowledge and skills in quality, compliance and technology

Required Qualifications: 

  • BS/BA in relevant field
  • 2+ (5 years preferred) years of people management experience 
  • Minimum 14 years of experience in the pharmaceutical industry 
  • Knowledge of GMP, GDP and other applicable regulations applicable to US and international regulatory agencies 
  • Experience with temperature-controlled logistics  
  • In depth knowledge and experience with quality systems, corrective action and preventative action system, risk management, FMEA and other key tools for managing quality performance
  • Knowledge of validation (shipping, equipment, facilities).  
  • Experience in regulatory inspections  

Preferred Qualifications: 

  • Experience with quality management systems (QMS), electronic documentation management systems (EDMS) and ERP systems  
  • Must be capable of assessing compliance to quality requirements using sound judgement and decision-making skills  
  • Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential  
  • Innovative, proactive, and resourceful; committed to Quality and continuous improvement  

 

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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