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Director, R&D Quality

Employer
Seagen, Inc.
Location
Bothell, WA, United States
Start date
Feb 20, 2019

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Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Summary:

This position reports to the Director or Senior Director, R&D Quality, and is responsible for the development and growth of the R&D Quality Electronic Systems function within Seattle Genetics. In addition to Information Technology, areas that will require support may include GLP, pharmacovigilance, regulatory operations (regulatory submissions and CMC information), clinical research operations, biostatistics, data management, product labeling, and promotional materials. The role includes independent assessment and gap analysis of current GCP/GLP electronic systems in use; conduct of internal and external, domestic and international GCP/GLP systems audits in accordance with applicable government regulations, ICH-GCP, and Seattle Genetics SOPs. Additionally, this position will manage activities to support the validation lifecycle of GCP/GLP computerized systems at Seattle Genetics.

Responsibilities:
  • Provide guidance and strategic planning regarding validation requirements of current GCP/GLP electronic systems including software/system validation projects for both COTS and in-house developed electronic systems
  • Provide leadership to cross-functional teams
  • Creation, evaluation and implementation of standard operating procedures (SOPs) and systems needed to comply with regulatory requirements
  • Independently plan & lead domestic and international audits according to an audit plan, applicable regulations and Seattle Genetics SOPs, including audits of Clinical and Nonclinical service providers and internal systems and processes
    • Assess findings identified during audits and summarize for the auditee at audit close
    • Prepare and distribute written audit reports in a timely manner and ensure responses to audit findings adequately address the issue(s) prior to audit closure
    • Report significant and/or serious compliance issues to RDQ Management
  • Support clinical study teams by:
    • Participating in the evaluation/qualification of technical service providers to ensure that electronic systems generating/capturing study data and the corresponding data management systems are adequate to meet study team requirements and applicable government regulations
    • Conducting audits of companies hosting computerized systems used by clinical or GLP functions or teams (eg, EDC or Randomization Services)
  • Manage activities to support the validation lifecycle of GCP/GLP computerized systems at Seattle Genetics
    • Facilitate development of sound risk-based validation strategies and plans
    • Providing CSV compliance advice to cross functional teams with R&D at Seattle Genetics
    • Ensure GCP/GLP computerized systems are validated and controlled to comply with US and EU regulations
  • Assist with the organization, preparation, coordination, and documentation of regulatory inspections


Qualifications:
  • Experience developing and growing a GCP/GLP electronic systems organization including hiring personnel, drafting processes and procedures and gap analyses
  • Team player with well-developed communication and management skills
  • Current knowledge of Code of Federal Regulations, EU Regulations, and ICH Guidelines governing clinical trials, GLP research, and expectations regarding the control of computerized systems used for these purposes
  • Knowledge of auditing techniques, including auditing of computerized systems
  • Knowledge of software development methodologies and validation requirements for GCP/GLP electronic systems
  • BA/BS in a related field + 15 years of relevant industry experience
  • Experience of computerized system validation following industry standards and GCP/GLP is required, including ability to interpret and apply ICH guidance, regulatory guidance, and pharmaceutical industry guidance
  • Up to 30% travel time


As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics 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.

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