Seagen

Associate Manager Quality Document Management System & Compliance

Development - Bothell, Washington

Description

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

The Associate Manager, Doc Control is responsible for the management, operation, and upkeep of the Development’s Quality Document Control system and processes to support GCP/GLP/GVP programs. The core function consists of day-to-day Electronic Data Management System (EDMS) tasks, handling document process compliance, and procedural technical writing.

Principal Responsibilities:

• Independently oversee consistency and uniformity of procedural documents as well as work with document owners to shepherd them through the revision and approval workflow process with no supervision
• Manage the periodic review process for GCP/GLP/GVP procedural documents, render decisions and determine next steps for these workflows
• In collaboration with leadership create procedural writing best practices. Ensure documents, forms, and templates adhere to the required formatting requirements
• In collaboration with the business create, issue, and reconcile Controlled Forms and E-Forms
• Cross train on other document control functions
• May manage the Document Control program
• Develop and provide training, job aids and standards for Doc Control and procedural technical writing
• Assist junior or mid-level staff with performing document management assessments & activities
• Working closely with the manager, identify process improvement opportunities to streamline the doc control and procedural technical writing processes
• Work with users to ensure timely completion of system and process related tasks. Communicate widely to users for needed follow-up notifications

Required Qualifications:

• GCP/GLP/GPvP experience in biotech/pharmaceutical environment.
• Experience with Learning Management Systems (LMS) and Electronic Document Management Systems (EDMS), with preference given to applicants with Veeva Quality systems experience.
• Smartsheet or related project/task management tool experience.
• Demonstrated success managing quality systems such as deviations, change controls, etc.
• Demonstrated knowledge and understanding of quality compliance principles with specific focus on GCP/GLP/GPvP.
• Develop new metrics, evaluate metrics, and report to dept management.
• Strong writing skills – experience in technical writing of procedural documents.

Education:

• Minimum of 6 years’ experience working in a GxP regulated environment.
• Bachelor’s degree or higher, life sciences preferred.

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, 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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/25/2022