Seagen

Quality Assurance Senior Specialist

Technical Operations & Process Sciences - Bothell, United States

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!

Summary

A Senior Specialist in Quality Programs is responsible for managing the day-to-day activities to support the change management quality program. Responsibilities include but not limited to training staff on change management; providing support to staff in completion of change control tasks; supporting the electronic Quality Management System development and updates; maintaining SOPs and creating guidance documents; developing metrics and following-up on trends; managing third-party communication associated with changes affecting external organizations; driving continuous improvement efforts to align with business need and current industry best practices. No people management responsibility is required.

Principal Responsibilities:

• Manage the change control quality program, including: assisting staff at various levels with performing change control tasks within the eQMS; providing training on using the program; leading continuous improvement activities; monitoring the program and system for compliance; collecting metrics and following-up on trends; etc.
• Develop and maintain relationships with cross-functional Seagen staff and third-parties to support internal and external change control activities
• Represent the Quality Programs group on cross-functional teams participating in various operational programs and other continuous improvement activities
• Write/revise quality procedures or other department operating procedures
• Provide support for audits and inspections as a subject matter expert
• Guide the successful completion of projects and may function in a project leadership role
• Make independent decisions within the defined procedures and practices of the change management program, with oversight from management on more complex issues
• Cross-functional, ad-hoc support of related quality programs, such as Deviation and CAPA management

Qualifications:

• Minimum 6 years in GMP operations, preferably in the biopharmaceutical, pharmaceutical, or medical device industries
• Minimum 4 years of primary experience in change management, such as overseeing change management programs or leading diverse changes within organizations
• Strong technical skillset supporting work within various electronic systems including the electronic Quality Management System, Microsoft Office, and data analytics tools
• Strong working knowledge of cGMP, including ability to interpret and apply ICH guidance regulatory guidance, and pharmaceutical organization guidance
• Excellent written and oral communication skills
• Proven ability to work effectively in a fast paced team environment
• Ability to organize information in a consistent and readily retrievable manner
• Strong team player that can also work independently to achieve objectives

Education:

• Bachelor's degree in life sciences, engineering, or related field

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.

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.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 08/12/2022