Director, Research and Development Quality (RDQ) Operations

  • Seattle Genetics
  • Bothell, WA
  • Sep 19, 2018
Research

Job Description


Seattle Genetics


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.

Regulatory Affairs . Bothell, Washington

Description

Summary:

The Director of Research and Development Quality (RDQ) Operations works in a regulated environment and is responsible for coordinating and driving activities relative to the Research & Development Quality team. This individual manages systems, processes and projects and serves an essential role in facilitating cross-functional compliance efforts within Development and with other Seattle Genetics organizations including Research, Quality Systems, Quality Compliance, and Corporate Compliance. The role may also include interactions with external parties including clinical service providers and co-development partners. The role requires active involvement to meet timelines and to recognize and resolve problems or conflicts. It also entails collegial interaction with functional peer groups at various management levels. Gaining RDQ team and cross-functional cooperation, managing timelines, creating and delivering presentations of technical information, communicating diplomatically, and solving problems are keys to success.

Responsibilities:

  • Contribute to the functional excellence of the department by overseeing the development and continuous improvement of processes, procedures, and tools related to RDQ practices, including:
    • Determining system requirements for infrastructure projects needed to support activities of RDQ
    • Audit Management System
    • RDQ ECMS
    • Inspection Management System
    • Trending tools
  • Apply project management expertise, methodologies, and department standards to be strategic in planning and implementation of RDQ initiatives
  • Participate in long-range and annual budget planning
  • Participate in audits as needed
  • Employ quality tools (eg, graphs/figures, quality metrics, computer-based training tools,) to meet specific quality objectives
    • Audit trends/ quality metrics
    • Quarterly Quality Reports to Management
    • Training materials
  • Partner with TOPS Quality to represent R&D requirements for corporate Quality Management Systems and initiatives, including
    • Deviation/CAPA management
    • Planned Deviations
    • Document control
    • Inspection management
    • Learning management
  • Partner with IT to provide R&D content for the clinical Quality Management System Knowledge Center
  • Chair periodic Clinical Quality Council meetings
  • Interact with corporate/co-development partnersand technical service providers to develop Quality Agreements
  • Communicate effectively with team members, senior leaders, and the broader organization
  • Coordinate and manage regulatory inspections (front or back room)

Qualifications:

Position Requires:
  • BA/BS degree (advanced degree preferred) and a minimum of 10 years' experience in the pharmaceutical/biotechnology industry, with at least 7 years in GCP
  • Knowledge of Code of Federal Regulations, ICH Guidelines and EMA directives and regulations pertaining to clinical research
  • Proficiency in MS Word, Excel, PowerPoint, MS Project, Adobe, and database applications

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.

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