Quality Associate III - Quality Compliance Data Analytics

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!

Position Summary :

The Quality Associate III, Quality Compliance Data Analytics is responsible for executing Quality Compliance Data analysis and monitoring, identifying, and reporting signals in the compliance data for further action.

The job also requires activities such as participating in functional teams, answering questions from internal staff, ad-hoc data analysis to support investigations, regulatory audits, and other business functions.

The position will support all other compliance functions as necessary such as audit support, maintenance of Quality Compliance SharePoint, complaint investigations, and regulatory intelligence.

This is a hybrid position.

Principal Responsibilities :

• Generate and analyze Quality Compliance metrics for monthly KPI reporting
• Maintain Power BI KQI dashboards
• Establish and generate periodic complaint trend reporting program
• Monthly evaluation of compliance data and support of Compliance Committee meetings
• Provide and evaluate reports from Veeva for analysis and support of internal and audit requests
• Help update or develop processes and workflows to reflect continuous improvements through data evaluation
• Liaise with SGEN sites and affiliates
• Support updates to Quality Compliance SharePoint sites
• Participate in risk assessment, investigation activities and decision-making for compliance programs through data evaluations
• Support regulatory inspections
• Other duties as assigned including Veeva module testing for Incident Escalations, audits, and complaints

Expected Qualifications :

• BS degree required, preferably in Engineering, physical sciences, or data analytics.
• 5+ years with BS
• Prior metric generation and data analysis experience
• Experience with statistical analysis and process monitoring
• Very detail-oriented team player with effective planning, organization, and execution skills
• Excellent communication skills with internal and external personnel essential
• Experience with electronic systems such as Electronic Documentation Management System (EDMS), Quality Management System (QMS)
• Strong computer skills with Word, Excel, PowerPoint, and statistical software
• Ability to work effectively and independently in a fast-paced environment
• Innovative, proactive, and resourceful; committed to quality and continuous improvement
• Ability to anticipate and mitigate challenges

Preferred Qualifications :

• Specialty knowledge of data analytics tools, such as Power BI, JMP, Minitab, and Tableau
• Prior experience with Statistical Process Control (SPC), control charts, Six Sigma tools, and identifying sources of variance and emergence of trends

The hiring pay range for this position is $88,000 to $114,000 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 and an annual bonus.