Seagen

Senior Quality Compliance Specialist

Technical Operations & Process Sciences - Bothell, United States

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 Sr. Specialist Quality Compliance is responsible for supporting site compliance activities at Seagen’s North Creek Manufacturing Facility. As part of the site compliance team the candidate will be responsible for ensuring inspection readiness for both health authority inspections and partner audits. The candidate will also be responsible for the execution and oversight of the site self-inspection program (ensuring products and processes comply with applicable global standards, regulations, and guidelines), reporting of inspection/audit metrics, coordinating the generation, review, and approval of site related audit/inspection responses and CAPAs.

Principal Responsibilities:

• Support site business processes related to hosting internal and external audits
• Participate in both “Front room” and “Backroom” activities during audits and inspections
• Execute the site self-Inspection program ensuring compliance with applicable standards, regulations, and applicable procedures at the North Creek manufacturing site
• Partner with key stakeholders of North Creek specific vendor for the creation and/or review of Quality Agreements ensuring consistent agreements meeting regulatory and Seagen expectations
• Updating and Maintaining the Site Master File as it relates to internal manufacturing site activities Operation Procedure creation/review and approval as required
• Other Quality/compliance activities as required
• Quality review and approval of CAPAs and Deviations are necessary
• Independently facilitate site meetings with cross functional groups to review and resolve/mitigate compliance issues
• Ensure that compliance issues/concerns are appropriately escalated to site and/or global leadership

Required Qualifications:

• Bachelor’s degree in a scientific discipline or equivalent with 10 years or more relevant industry experience in a regulated pharmaceutical, biologics, or biopharmaceutical environment.
• Inspection experience in a biotech or pharmaceutical environment.
• Strong working knowledge of cGMPs
• Demonstrated organizational, problem solving and decision-making skills.
• Strong negotiating, influencing and PM skills.
• Excellent communication and interpersonal skills with ability to interface to all levels within organizations.

Preferred Qualifications:

• Experience with the manufacture/testing of clinical and commercial pharmaceutical/biopharmaceutical products
• Internal/External auditing experience (Lead auditor or co-auditor responsibilities)
• Ability to communicate effectively to drive actions and inform of project status
• Ability to lead meetings (using the DAI model) and provide metrics
• Experienced with various electronic quality management systems (Veeva, AuditUtopia etc.)
• Excellent technical writing and communication skills
• Knowledgeable and familiar with the application of risk management principles

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 $103,000 to $133,000 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.

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: 03/11/2023