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 Sr. Specialist, Quality Management Systems is primarily responsible for owning and managing the GMP Training Program and providing expert guidance for the Everett, WA site. The Sr. Specialist acts as an advisor to management and customers on advanced technical work and applications. Full understanding of area of specialization, good knowledge of other related disciplines, and ability to merge ideas across disciplines is required.

This role partners closely with Corporate Quality Training, other Seagen site training teams, and internal cross-functional teams within Everett (i.e., Operations, Quality Control, Technology, Engineering, Facilities and Quality Assurance.) Seagen’s new cGMP manufacturing facility “project Launchpad” is being built in Everett, Washington, just North of Seattle. Launchpad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs).

Principal Responsibilities:

Quality Systems – General

• Serve as the GMP Training Program owner for the Everett site, which includes:
  • Make independent decisions within area(s) of expertise, with support from management on more complex issues
  • Represent Quality Systems on cross-functional teams or teams with external parties
  • Author and own GMP procedures (policies, operating procedures and work instructions) and QMS documents within scope of responsibility
  • Create, improve, maintain, and deliver site and team trainings for performance of Quality Program(s)
  • Define, produce, and present key system and site performance metrics to monitor Quality Program training effectiveness and drive improvement. Provide regular reports to management and governance teams
  • Process complex QMS records that may involve external parties
  • Serve as site Quality Program SME for inspections and audits
  • Assist with the resolution of regulatory/audit commitments
  • Partner with corporate quality to implement corporate requirements at the site
  • Provide customer service and user support at the site by providing guidance and tools
  • Actively seek out, champion, and implement process and system improvements
  • Participate on cross-functional or external teams and continuous improvement activities
  • Provide backup support for other site Quality Programs, as required

• Responsible for all site GMP Training Program administration including site use of ComplianceWire training system
• Administer training system for site including but not limited to user access, creating training modules from customer content, organizing training assignments, providing customer support for questions, and providing training metrics
• Represent site training on the cross-functional training system administrators' team.
• Train and mentor other training system administrators
• Manage and perform site activities within the Training Program, including:
  • Partner with Corporate Quality to deliver new hire orientation and support onboarding
  • Gather required documentation from new hires (signature form, CV, etc.)
  • Administration and filing of paper records
  • Assist in setting up training classes in ComplianceWire
  • Assist junior to mid-level staff with creating and structuring training content
  • Perform document management assessments and activities
  • Develop new business processes
  • Participate in GMP training activities as the Quality Program owner

• Participate as the site Training Program SME in audits and inspections, as needed
• Lead continuous improvement activities for the GMP Training Program that may involve a team
• Other duties as assigned

Expected Qualifications:

• Bachelor's degree in a relevant field
• 10+ years relevant experience in GMP operations, preferably in the biopharmaceutical or the pharmaceutical industry
• Working knowledge of cGMP, including ability to understand and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance
• Knowledge of good documentation practices within the Pharma or Biopharma industries
• Excellent written and oral communication skills
• Excellent customer service and collaboration skills
• Ability to manage routine and non-routine workload with little-to-no oversight
• Experience with applicable software (e.g., electronic Document Management System)
• Proficient with Office 365 suite
• Basic knowledge of continuous improvement principles and practices
• Equivalent education and experience may substitute for stated requirements

Preferred Qualifications:

• Facility start-up experience
• Application of adult learning theory in the creation of training content

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 $139,000 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.

#LI-DD1