Seagen

Quality Systems Specialist

Description

Summary

The Quality Systems Specialist is responsible for supporting the development and maintenance of Seagen's Pharmaceutical Quality System (PQS) in accordance with internal standards, regulatory requirements, and applicable guidelines. The individual will manage cross-functional project teams and will be accountable for ensuring risks within Seagen's PQS are consistently and effectively assessed, controlled, communicated, and reviewed. The individual must be able to interact with staff at various management levels.

Principal Responsibilities:

• May manage the Quality Risk Management (QRM) program, including developing risk management tools, developing and providing training, as well as executing on the program procedures, answering questions, and leading validation activities
• May manage the Management Review/Metrics program, including updating guidance for metrics development, assisting departments with defining metrics, scheduling/participating in review meetings, preparing reports, and tracking metrics and action items
• Assist with other quality systems such as change control, data integrity, deviations, CAPA, and training, as needed, including processing records, sending notifications, collecting metrics, etc.
• Guide the successful completion of department projects and may function in a project leadership role
• Write/revise, review, collaborate on, and approve program or department standard operating procedures, and ensure documents reflect current practices
• Participate as an SME in audits and inspections under the direction of management, as needed
• Represent Quality Systems on cross-functional teams or teams with external parties
• Lead continuous improvement activities that may involve a team
• Make independent decisions within the defined procedures and practices of the quality program they lead, with oversight from management on more complex issues
• Mentor entry-level associates
• May manage contract employees
• Other duties as assigned

Qualifications:

• 8+ years 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
• Working knowledge of current industry practices and standards
• Advanced expertise with Office 365, SharePoint, Power BI
• Experience with applicable software (e.g. Learning Management System, electronic Quality Management System, data analytics, etc.)
• Excellent written and oral communication skills
• Demonstrated problem-solving skills and techniques commensurate with job level
• Ability to manage routine and non-routine workload with minimal oversight

Education:

Bachelor's degree in relevant field or equivalent experience; or 11+ years of relevant quality assurance, manufacturing, or quality control experience in the biotech or pharmaceutical industry.

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 02/26/2021