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!
Seagen Research and Development Quality is seeking an Associate Director, Governance and Quality Analytics to join our Team that oversees GCP, GLP, GVP and Electronic Systems activities at Seagen. In this role you will be responsible for implementing and leading the Development Quality Governance and Analytics program. This program will help shape the strategic direction for the development and utilization of quality metrics, analytics and insights that facilitate the oversight of quality performance. You will establish and facilitate governance meetings for analytics reviews. In addition, this leader is responsible for following up and reporting meeting outcomes and action items. This role helps ensure independent oversight and presents a strong voice of Quality Assurance.
In addition to metrics and analytics knowledge, this individual must have strong facilitation and leadership skills, expert knowledge of the regulations governing drug development and post-marketing activities, and exceptional presentation skills.
- Establish process and tools to intake Development information and create risk-based executive level visuals as outputs
- Plan, facilitate, and provide follow-up support for governance meetings
- Create analytics presentation slide decks for governance meetings and Executive Quality Review
- Implement a Risk Management framework and Issue Escalation processes for Development and interacting with other similar roles within Development
- Present analytics presentations to various levels and influence executive management to take action for higher risk analytics
- Drive quality performance over time across Development GCP, GLP, GVP and electronic systems activities at Seagen
- Participate in determining appropriate quality thresholds for acceptable and at-risk performance
- Share insights from metrics and through other mechanisms to uncover trends, mitigation requirements, and predictive analysis
- Lead regular Quality Forum Review cycle to assure management visibility of quality performance across Research & Development
- Develop the Quality Governance program including processes and ensure consistency of terminology and tools as it is applied in various quality processes (e.g., audit, vendor, quality governance, IT etc.)
- Lead regular Quality Governance Reviews to drive active GCP, GLP, GVP and electronic systems monitoring and mitigation
- Supervise, develop, train and manage internal staff as needed. This includes fostering a commitment to quality in individuals and a culture of quality within the organization
- Bachelor’s degree in related field with 12+ years in biotech/pharma analytics; Master’s degree in related field with 10+ years in biotech/pharma analytics; or PhD in related field with 8+ years in biotech/pharma analytics
- Expert facilitation and organizational skills
- Governance, Quality Metrics and Analytics experience
- Experience in building a Governance and Analytics Program for end-to-end data analytics, trending and visualizations using tools such as Spotfire, Tableau, Power BI, or equivalent
- Must have broad GCP/GLP/GVP experience. Compliance experience in a Bio-pharma sponsor organization required
- Proven exceptional verbal, written, interpersonal skills to include delivering presentations to executives
- Demonstrated effective verbal and written communication skills
- Excellent organizational and project management skills
- Able to lead and mentor effective cross functional teams
- Ability to travel approximately 25% required
- Expertise in building and maintaining SharePoint Online sites.
- Experience interacting with Data Sciences groups.
- Experience with DataBricks, Domino, standard clinical trials applications such as Argus, CTMS, EDC, RIM, etc.
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.
The hiring pay range for this position is $158,000 to $205,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.
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.