Associate Director, Global 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:  

This AD of Global Quality Validation is responsible for building, maintaining, evolving the overall Validation Policy at Seagen and having oversight over the validation programs through their lifecycles to ensure compliance with regulatory requirements, guidance, and applicable industry standards. This position is accountable for ensuring that the validation requirements are met in a compliant manner; understands and applies knowledge related to applicable regulations, business processes, and industry best practices; and works across sites with Facilities, QC, IT, and Manufacturing to ensure strategic and risk-based decision making in the development, management, and continuous improvement of validation programs. 

Responsibilities:  

  • Leadership of Global Quality Validation and its sub-functions responsible for the compliance oversight of GXP instrument, equipment, facility, and utility qualifications; of computer system validations for enterprise, automation, or equipment-linked systems; and of shipping, cleaning, and process validations 
  • Provide strategic leadership to Global Quality Validation including:
    • Establishing and executing strategic team goals ensuring compliance and continuous improvements  
    • Identifying resource requirements to support business goals and objectives 
    • Leading the hiring, mentoring, and developing of staff 
    • Participating in the development of strategy and goals for staff 
    • Critically evaluating infrastructure to develop a strategic vision for continuous improvement, enhancements, and future growth 
  • Provide vision and set strategy for the compliance oversight of Seagen validation programs including:   
    • Establishing and maintaining best practices by monitoring regulatory and compliance trends within the biopharmaceutical industry and recommending risk-based approaches  
    • Working with leadership of other functions to influence company direction and strategically align Quality Validation function to support and meet those objectives 
    • Leading cross-functional and cross-site validation meetings to ensure robust communication and collaboration, and coordination of cross-program elements and activities 
    • Providing support on operational improvement initiatives, techniques, and data analysis to support Quality decisions 
    • Researching, implementing, and maintaining appropriate technology to improve and standardize the business process of validation 
    • Assessing remediation action plans based on cross-functional metrics, audits, and inspections 
    • Designating training requirements on overall validation concepts and policies 
  • Establish strong relationships and engage with business groups to gain cooperation, foster collaboration, and influence outcomes in a positive way 
  • Write/revise, collaborate on, and approve Quality directives and operating procedures that impact multiple departments or programs based on industry best practices; ensure controlled documents meet directive and regulatory requirements 
  • Ensure appropriate escalation of critically impactful quality issues that arise during the management review process 
  • Participate in the evaluation and approval of critical or highly complex validation-related changes, investigations, and CAPA 
  • Represent Global Quality in cross-functional leadership teams  
  • Sponsor cross-functional continuous improvement projects or teams 
  • Participate on management teams preparing for audits and inspections, as needed 
  • Other duties as assigned 

Qualifications:  

  • 16+ years in GMP operations, preferably in the biopharmaceutical or the pharmaceutical industry 
  • 5+ years of people management experience 
  • Strong working knowledge of validation requirements following industry standards (e.g., GAMP and ISPE) and cGMP is required, including ability to interpret and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance 
  • Working knowledge of current industry practices and standards 
  • Excellent written and oral communication skills 
  • Demonstrated problem-solving skills and techniques commensurate with job level 
  • Ability to manage routine and non-routine workload of direct reports  
  • Bachelor's degree in relevant field; or Associate’s degree +2 years of relevant experience in the biotech or pharmaceutical industry 

 

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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