Director R&D Quality And Continuous Improvement

Seattle Genetics Bothell , WA 98021

Posted 2 months ago

Summary:

Research and Development Quality (RDQ) is the Clinical Quality Assurance group responsible for oversight of GCP, GLP and GPvP with the Development organization at Seattle Genetics, Inc..

The R&D Quality (RDQ) Bridge Director Quality and Continuous Improvements, will be responsible for building a team within RDQ with the purpose of promoting quality-by-design and embedding a culture of quality in all aspects of clinical trial development within the Seattle Genetics, Inc. Development organization. This new position within RDQ will play a key role in promoting excellence in standards, processes, analytics, and business intelligence while keeping the execution of quality and implementation of process improvements within the functional and operational areas.

Responsibilities:

  • Provide expert direction to team to oversee procedural documentation, process management, and process improvement in conjunction with cross-functional stakeholders and subject matter experts

  • Perform content review and quality control for a portfolio of documents to drive alignment with Seattle Genetics policies and best practices

  • Propose and implement plans to resolve complex issues and execute corrective actions

  • Drive continued team progress on multiple projects during and between meetings

  • Determine actions required to achieve team goals and leverage junior staff accordingly

  • Manage junior staff and develop their capabilities in alignment with organizational priorities

  • Synthesize complex data and present findings clearly to senior leadership

  • Collaborate with key stakeholders to assess process alignment and prioritize revisions as necessary to ensure continued relevance and

  • applicability

  • Support budget creation and resource allocation decision-making within the organization

  • Advise on the development and delivery of internal training materials on an as-needed basis

  • Drive standardization and the adoption of best practices across the Development Operations organization

Skills:

  • Execute change management effectively across cross-functional teams

  • Synthesize inputs from various stakeholders into coherent deliverables and outputs

  • Collaborate flexibly with virtual and remote team members and colleagues

  • Analyze problems and logically structure approaches to resolve identified challenges

  • Fluency with Microsoft Office suite, including Visio and Project

  • Up to 25% travel

  • Project Management:

  • Navigate projects amidst ambiguous situations and changing priorities

  • Manage multiple projects while monitoring quality work product from self and team

  • Align various stakeholders and drive teams toward a common goal

Qualifications:

  • 10+ years of relevant project management and business process improvement experience with a Bachelor's degree OR 8+ years of relevant project management and business process improvement experience with a Master's degree in the biotechnology or pharmaceuticals industry

  • 5+ years of experience managing teams and direct reports in a business operations or technical processes environment

  • Familiarity with highly regulated industry environments or drug development including clinical trial processes, quality management systems and quality control tools

  • Excellent program and project management, consensus-building, and leadership skills

  • Fluency in Microsoft Office suite (including Visio, Project, and Excel)

  • Excellent ability to communicate across the organizational hierarchy and cross-functionally

  • Exceptional ability to manage changing priorities and ambiguity

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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