Manager, External Quality Operations

Technical Operations & Process Sciences Zug, Switzerland


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 Quality Assurance Manager, External Supply Operations, Europe, based in Zug, Switzerland, will act as a point of contact and subject matter expert for all quality related activities at contract manufacturers (CMOs) of API and Drug Product in Europe and APAC. 

Responsibilities: 

  • Serve as the point of contact and subject matter expert for all quality related activities at contract manufacturers (CMOs) of Intermediates, API and Drug Product in Europe and APAC 
  • Develop, monitor, and maintain positive relationships with CMOs and partners to encourage collaboration, improvements, transparency, and accountability 
  • Perform batch review activities ensuring products are dispositioned in accordance with company policies, international regulations, and quality agreements 
  • Coordinate cross-functional activities between the CMOs, partners, and stakeholders to enable efficient disposition of batches per schedule 
  • Manage and review deviations and changes per Seagen procedures and Quality Agreements 
  • Oversee and facilitate validation activities at the CMO sites 
  • Review cGMP Master Controlled Documents such as batch production records, specifications, and test methods for accuracy, compliance to procedures and regulatory requirements 
  • Develop and maintain Quality Agreements 
  • Collaborate with CMOs and corporate HQ on performance metrics, process monitoring, and product quality reviews 
  • Collaborate with manufacturing sites on preparation for health authority inspections and provides on-site support during inspections as needed 
  • Demonstrate effectiveness in task completion, decision-making, problem solving, communication, and collaboration

Qualifications: 

  • Minimum of Bachelor’s degree in a scientific discipline (Chemistry, Biology, etc.) – 8+ years' experience in the regulated pharmaceutical industry, with 3+ years in QA. 
  • Practical experience in pharmaceutical manufacturing and testing, with extensive knowledge of validation practices, GMPs and other applicable international regulations 
  • Experience with both small and large molecules preferred 
  • Experience working with CMOs 
  • Excellent communication skills and proven ability to work well with internal and external teams. Experience with virtual teams or multi-site organizations preferred 
  • Strong commitment to the accomplishment of tasks, adherence to procedures, and the initiative to identify opportunities for improvements 
  • Ability to anticipate and mitigate challenges and apply a flexible risk-based approach to problem solving 
  • Fluency in spoken and written English 
  • Ability to travel within Europe and APAC (up to 40%) as well as occasional travel to the Corporate HQ in the US 

 

As a leading employer in our industry, 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. To learn more about Seagen, please visit www.Seagen.com. 

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.   

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