Associate Director Site Compliance - 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! 

Position Summary:  

The Associate Director Site Quality Compliance is responsible for overseeing site compliance for Seagen Launch Pad facility in alignment with Corporate Directives. The position leads a site Quality team responsible for internal and external auditing, regulatory inspection management, product complaint investigations, coordination of vendor complaint and assessment of vendor-initiated changes impacting the site for our new manufacturing site (Drug Substance, Drug Product, Testing, Labeling and Packaging) in Everett, WA.  

The Associate Director is primarily focused on providing site Quality Compliance leadership while representing the site in collaboration with Corporate Quality Compliance. This position reports to the Launch Pad Site Quality Head. 
 
Principal Responsibilities: 

  • Serve as internal manufacturing site business process owner for internal and external auditing, regulatory inspection management/readiness, and product complaint investigations related to internally manufactured products 
  • Partner with Technical Operations to identify and qualify suppliers for Seagen Launch Pad or sister sites 
  • Owns and administers the self-inspection program covering all GMP activities and functions at internal manufacturing site. Publishes periodic status reports, and metric data reflecting the risk profile of GMP activities at Seagen Launch Pad. Ensure timely issuance of self-inspection reports, tracking responses and audit CAPA 
  • Manages site inspections readiness program of Seagen Launch Pad to ensure successful management of inspection by Health Authorities and Customers including logistics, tracking and monitoring of the inspection, and leading the response process.  Identifies SMEs and ensures inspection related topics are adequately prepared for and addressed. Partners with other Quality functions to staff the inspection management team 
  • Collobrates with Site Quality Head on regulatory audit CAPA responses and management of closure in timely manner 
  • Ensure high level of inspection readiness at internal manufacturing site at all times in collaboration with applicable SMEs and CMC teams 
  • Implement and manage the process of ensuring effective identification, control and management of regulatory and operational requirements, ensuring that all applicable law, regulations and current standards are implemented within the Seagen systems and processes 
  • Partner with Supplier Quality Management for  site vendor change notification process with change management staff 
  • Coordinate collection of data in support to the Annual Product Review/Product Quality Review for internally manufactured commercial products, enbsuring these are conducted in the required timeframe, provide the appropriate level of detail and required trend analysis 
  • Ensures Site Master File is implemented and maintained related to internal manufacturing site 
  • Develops and analyzes metrics for areas of responsibility 
  • Builds a strong Regulatory Intelligence network, in collaboration with TOPS Knowledge Management. Partners with other Quality and TOPS leaders to enhance standards processes and practices by incorporating regulatory knowledge and experience (gained through involvement with regulatory intelligence, due diligence and integration, best practice sharing, industry trade groups) into daily business 
  • Site Quality point of contact for management of investigations related to product defects, complaints, recalls, Biological Product Deviation Reports and Health Authority notifications for internally manufactured products. Active participant in mock recall drills. 
  • Provides strong leadership to the compliance team. Able to recruit, develop and retain first class self-driven talent into the compliance function. Is a collaborative partner with other Quality and TOPS leaders. Able to foster cooperation across multiple organizational functions and levels 

Expected 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 (recommended 16+ years overall relevant experience) 
  • Demonstrated ability to lead, develop and build GMP Quality and Compliance infrastructure and support Regulatory activities and obligations to Health Authorities 
  • Proven leadership skills and experience in meeting long term business and Quality objectives by aligning team strategy and vision with corporate business goals and objectives 
  • Expertise in GMP compliance and FDA/EMA regulations and proven track record of identifying and implementing updates to internal policies and practices based on changes in the regulatory landscape 
  • Successful implementation of Quality Risk Management tools and processes with proven track record of leveraging modern risk management principles in decision making and identifying and implementing process enhancements 
  • Skilled at guiding technically oriented business objectives within the framework of regulatory guidance and company quality systems, internally and externally, to achieve value-adding outcomes 
  • Established and innovative problem solver 
  • Has a bias for action and displays a sense of urgency. Must possess strong skills in leadership and communication 
  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships 
  • Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior team member and to engage and influence team members in a matrixed environment 

Preferred Qualifications: 

  • Bachelor’s degree in an engineering or science discipline plus 12+ years in GMP operations, preferably in the biopharmaceutical, pharmaceutical, or medical device industries; or 17+ years of industry experience without a BS 
  • 5+ years of people management experience 
  • Minimum 4 years of primary experience in Quality Risk Management, GMP Compliance, Regulatory Management 
  • Experience with FDA/EMA and Regulatory and Health Authority and/or management  
  • Strong working knowledge of cGMP, including ability to interpret and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance 
  • Excellent written and oral communication skills 
  • Proven ability to work effectively in a fast-paced team environment 
  • Ability to organize information in a consistent and readily retrievable manner 

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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