Associate Process Improvement Manager

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 Associate Process Improvement Manager is responsible for supporting and driving process initiatives for the Regional Clinical Trial Operations department. This position places an emphasis on clear communication, guiding process changes and change management efforts. The position will serve as a key contributor to process development and operational excellence.

Principal Responsibilities:

• Communicate process updates to the Regional Clinical Trial Operations (RCTO) department
• Closely collaborate with and support RCTO Process Owners, including driving document workflow processes in the quality document control system
• Lead process improvement teams, both specific to RCTO and cross-functional teams, to coordinate process improvements, including updates to controlled document guidance; align key stakeholders and drive decision-making related to process
• Assess impact of process changes and determine training needs
• Formulate strategies to address training gaps and conduct or coordinate training as appropriate
• Coordinate process-related projects on small to moderate scale
• Develop business practices and work instructions in collaboration with team members
• Oversee controlled document periodic review process for RCTO
• Oversee consistency and uniformity of procedural documents
• Collaborate with Research & Development Quality Doc Control to optimize quality document control system and reporting capabilities
• Develop tools and communication to support team member process navigation
• Present process changes at appropriate meeting venues to manage change for the team
• Promote department process compliance and quality
• Perform all duties and responsibilities in accordance with CFR, GCP/ICH, and other applicable guidelines

Qualifications:

• A minimum of 4 years of relevant pharmaceutical industry or clinical trial experience
• Experience with Electronic Document Management Systems (EDMS), Veeva Quality systems experience preferred
• Strong communication skills, both verbal and written, with experience in technical writing of procedural documents preferred
• Knowledge of CFR and GCP/ICH requirements
• Demonstrated ability to successfully manage multiple competing priorities
• Excellent planning and organizational skills
• Effective written and verbal communication and presentation skills
• Demonstrated clinical trial operational expertise and ability to lead others through change
• Proven interpersonal skills, including strong motivational skills and customer service
• Proficient with Microsoft Office software

Preferred Qualifications:

• Process improvement and change management experience

Education:

• Bachelor’s degree or equivalent or relevant and qualifying training/experience

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 $107,000 to $138,600 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.

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