Senior Manager GCP Quality Assurance

DevelopmentRemote, 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: 

Are you an experienced Quality Professional with significant GCP, GLP, and GVP internal process auditing and supplier relationship management experience?  We are looking for a leader and a problem solver who works well with abstract ideas and situations across functional areas of the business, internally and externally to analyze and plan internal process audits and, to resolve challenging supplier, service provider, and CRO issues. This role will provide key leadership at the manager or senior manager level.  The successful candidate will develop a robust internal process audit program and lead the newly created vendor management function within the R&D Quality organization.  This position will be in Bothell, WA, South San Francisco, CA or potentially remote.  This role will report to the Associate Director, Vendor and Internal Audit Management, Research & Development Quality (RDQ).  

Requirements: 

  • Work closely with Vendor Strategy Management and other R&D departments to ensure an effective selection and oversight process is in place for internal functions, vendors, service providers, and Contract Research Organizations (CROs) 
  • Ensure appropriate quality agreements, standards and specifications are established and maintained where required 
  • Conduct Risk Assessments, Risk mitigation planning, and monitoring to define the internal and vendor audit program. Lead internal and external audits 
  • Identify high priority risks to quality/compliance and prospectively implement mitigation plans 
  • Strategically utilize quality and compliance data (e.g., KPIs, QTLs, milestones) to monitor the vendor, service provider, and CRO portfolio quality and recognize potential risks and issues. Ensure project teams are aware of risks, issues, and general quality state. Analyze and interpret data from multiple sources to drive quality assessments 
  • Arrange global GCP/GLP/GVP internal audit, vendor, service provider, and CRO auditing program/calendar, balance workload, and arrange contract audit support when needed 
  • Interact with internal departments and CROs to address compliance and quality issues 
  • Provide QA leadership for internal function, vendor, service provider, and CRO issue management and escalation process 
  • Assist RDQ management in the development and implementation of strategic procedures and work practices to ensure continuous quality improvement 
  • Conduct effectiveness checks to verify the CAPA outcome 
  • Work with technical writers to help develop, review, and revise SOPs for GCP/GLP/GVP QA processes 

Responsibilities: 

  • Maintain and build effective relationships with key internal and external stake holders. 
  • Develop and communicate internal process and vendor risk assessments and risk mitigation to senior management 
  • Conduct risk assessments, risk mitigation planning, and monitoring. 
  • Incorporate risk, regulatory intelligence, QMS, and other key data into audit program definition activities.   
  • Assess and evaluate internal function and vendor changes from a quality perspective. 
  • Maintain and manage audit schedule. 
  • Perform routine onsite audits/evaluations at vendors and CRO facilities. 
  • Manage others performance in a matrixed environment (e.g., contract auditors, co-auditors) 

Qualifications: 

  • A minimum of 5 years' experience supporting EU and FDA GCP, GLP, and GVP functions 
  • Knowledge of clinical development process and Phase I-IV trial operations and the related regulations/guidelines 
  • Experience in planning, conducting and reporting of audits 
  • Experience in working with GCP vendors 
  • Experience developing SOPs, reviewing internal drug safety, clinical operations, regulatory and medical processes to ensure they are accurately represented in current SOPs 
  • Must have excellent communication skills (verbal and written) 
  • Highly organized with strong attention to detail, clarity, accuracy, and conciseness 
  • Experience with Veeva preferred
  • Working knowledge of 21 CFR 11 and Annex 11 

 

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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